Mucinex® D

Manufacturer: Reckitt Benckiser LLC
Effective date: 2026-04-21
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 01:59:03

Label at a glance#

ProductMucinex D Maximum Strength

Active ingredientGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Contacts and useful links#

PhoneLabel contact1-866-682-4639

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each extended-release tablet) Purposes
Guaifenesin 1200 mg Expectorant
Pseudoephedrine HCl 120 mg Nasal Decongestant

OTC - PURPOSE SECTION

Active ingredients (in each extended-release tablet)	Purposes
Guaifenesin 1200 mg	Expectorant
Pseudoephedrine HCl 120 mg	Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not useif you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; FD&C yellow no. 6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

PRINCIPAL DISPLAY PANEL - 24 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

NDC 63824-041-24

Mucinex®D
1200 mg guaifenesin & 120 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT
& NASAL DECONGESTANT

12
HOUR _®

Clears Nasal/Sinus Congestion
Thins and Loosens Mucus
Immediate and Extended Release

24
EXTENDED-RELEASE TABLETS

Label

label 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1244675	guaiFENesin 1200 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	12
1244675	12 HR guaifenesin 1200 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0363824041247	GTIN-13: 0363824041247 EAN-13: 0363824041247 GTIN-12: 363824041247 UPC-A: 363824041247 GTIN storage (14 digits): 00363824041247	63824-041 updated label 1.jpg
QR code link	QR Code	www.mucinex.com/pages/product-faqs		63824-041 updated label 2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-041-12	Mucinex DMaximum Strength	1 in 1 CARTON	TABLET, EXTENDED RELEASE	1	12
63824-041-12	Mucinex DMaximum Strength	12 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	12	12
63824-041-24	Mucinex DMaximum Strength	12 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	12	12
63824-041-24	Mucinex DMaximum Strength	2 in 1 CARTON	TABLET, EXTENDED RELEASE	2	12
63824-041-36	Mucinex DMaximum Strength	3 in 1 CARTON	TABLET, EXTENDED RELEASE	3	12
63824-041-36	Mucinex DMaximum Strength	12 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	12	12
63824-041-71	Mucinex DMaximum Strength	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1	12
63824-041-71	Mucinex DMaximum Strength	24 in 1 CARTON	TABLET, EXTENDED RELEASE	24	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-041-24	EA - Each	63824-041	61015d30-476d-485d-9f12-8b703c060b4b	1	2012-07-24
63824-041-36	EA - Each	63824-041	47d8722a-355a-4e8b-bc31-657a5615e308	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	6
Pseudoephedrine Hydrochloride	ACTIVE INGREDIENT	6V9V2RYJ8N	6
Guaifenesin	ACTIVE MOIETY	495W7451VQ	6
Pseudoephedrine	ACTIVE MOIETY	7CUC9DDI9F	6
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	6
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	INACTIVE INGREDIENT	HHT01ZNK31	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	6
FD&C yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	6
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Mucinex D Maximum Strength
Guaifenesin and Pseudoephedrine Hydrochloride
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C YELLOW NO. 6
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
GUAIFENESIN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63824-041	63824-041-24, 63824-041-71, 63824-041-36, 63824-041-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
GUAIFENESIN	495W7451VQ	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
FD&C yellow NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C yellow NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C yellow NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C yellow NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C yellow NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	HHT01ZNK31	TABLET, EXTENDED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, EXTENDED RELEASE / ORAL		1472 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021585-001	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2004-06-22
N021585-002	MUCINEX D	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2004-06-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021585-001	MUCINEX D	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2004-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021585-002	MUCINEX D	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2004-06-22	`4b0b4de00fa7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021585-001	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	6372252	2020-04-28		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021585-002	7838032	2020-04-28		Drug product		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021585-001	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	6372252	2020-04-28		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021585-002	7838032	2020-04-28		Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021585-001	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-001	6955821	2020-04-28	U-686	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	6372252	2020-04-28		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	6955821	2020-04-28	U-686	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021585-002	7838032	2020-04-28		Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021585-001	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-001	6955821	2020-04-28	U-686	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	6372252	2020-04-28		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	6955821	2020-04-28	U-686	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021585-002	7838032	2020-04-28		Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021585-001	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-001	6955821	2020-04-28	U-686	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	6372252	2020-04-28		Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	6955821	2020-04-28	U-686	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021585-002	7838032	2020-04-28		Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021585-001	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-001	6955821	2020-04-28	U-686	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-001	7838032	2020-04-28		Drug product	2010-12-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	6372252	2020-04-28		Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	6955821	2020-04-28	U-686	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021585-002	7838032	2020-04-28		Drug product		`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex D Maximum Strength	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9264518-2f2c-498f-b733-6f3397336a01	2026-04-21	Warnings	Exact identifier ndc (package): 63824-041-24 ndc (package): 63824-041-71 ndc (package): 63824-041-12 ndc (package): 63824-041-36 ndc (product): 63824-041 ndc11 (package): 63824004112 ndc11 (package): 63824004171 ndc11 (package): 63824004136 ndc11 (package): 63824004124 spl id: 4ffd9424-45c5-31f1-e063-6394a90a0521 spl set id: d9264518-2f2c-498f-b733-6f3397336a01

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.