Reckitt Benckiser
FDA Approved Drugs

Reckitt Benckiser

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

OTC
  • Total Records 8
  • Latest Approval Date Dec 22, 2025
  • Data Source FDA
  • First Approval Date Oct 08, 1982
Company Overview

Company

Reckitt Benckiser

Country

United Kingdom

Website

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Company Snapshot

Reckitt Benckiser

103 - 105 Bath Road, Slough, Berkshire, SL1 3UH

United Kingdom

www.rb.com/home View on Map
FDA Approved Drug Records ( 8 records )
1982
08 Oct
OTC Application: 18658

Drug Name

DELSYM

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

1982-10-08

18658 / 1

Active Ingredient

DEXTROMETHORPHAN POLISTIREX

Application Number

18658

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

1982-10-08

Regulatory Status

OTC

2002
12 Jul
OTC Application: 21282

Drug Name

MUCINEX

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-07-12

21282 / 1

Active Ingredient

GUAIFENESIN

Application Number

21282

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-07-12

Regulatory Status

OTC

2002
18 Dec
OTC Application: 21282

Drug Name

MUCINEX

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2002-12-18

21282 / 2

Active Ingredient

GUAIFENESIN

Application Number

21282

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2002-12-18

Regulatory Status

OTC

2025
22 Dec
OTC Application: 217338

Drug Name

MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM

Product Number

1

Dosage Form

-

Strength

30MG;600MG;110MG

Approval Date

2025-12-22

217338 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM

Application Number

217338

Product Number

1

Dosage Form

-

Strength

30MG;600MG;110MG

Approval Date

2025-12-22

Regulatory Status

OTC

2004
22 Jun
OTC Application: 21585

Drug Name

MUCINEX D

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2004-06-22

21585 / 1

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21585

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2004-06-22

Regulatory Status

OTC

2004
22 Jun
OTC Application: 21585

Drug Name

MUCINEX D

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2004-06-22

21585 / 2

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

21585

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2004-06-22

Regulatory Status

OTC

2004
29 Apr
OTC Application: 21620

Drug Name

MUCINEX DM

Product Number

1

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2004-04-29

21620 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

21620

Product Number

1

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2004-04-29

Regulatory Status

OTC

2004
29 Apr
OTC Application: 21620

Drug Name

MUCINEX DM

Product Number

2

Dosage Form

-

Strength

30MG;600MG

Approval Date

2004-04-29

21620 / 2

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

21620

Product Number

2

Dosage Form

-

Strength

30MG;600MG

Approval Date

2004-04-29

Regulatory Status

OTC

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Drug Status Breakdown
8 total
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

DELSYM

Application Number

18658

Product Number

1

Active Ingredient

DEXTROMETHORPHAN POLISTIREX

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

FDA Approved Drug Data

Approved drug product information

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