FDA.reportPublic FDA data

Mucinex DM

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-10-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:56:37

Label at a glance#

ProductMucinex DM, CVP HEALTH
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure12 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: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep

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 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients
(in each extended-release bi-layer tablet) 		Purpose
Dextromethorphan HBr 30 mgCough suppressant
Guaifenesin 600 mgExpectorant

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:
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the intensity of coughing
    • the impulse to cough to help you get to sleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • if 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

  • 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

  • cough lasts more than 7 days, comes back, or occurs with 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 or 2 tablets every 12 hours; not more than 4 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; D&C yellow #10 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)
You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Product manufactured by:
Reckitt Benckiser, Parsippany, NJ 07054-0224

Repackaged and distributed with permission of manufacturer by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

Mucinex ® DM 2ct, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucinex® DM

600 mg guaifenesin & 30 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

[caplet image]

  • Controls Cough
  • Thins And Loosens Mucus

2 EXTENDED-RELEASE BI-LAYER TABLETS

[Lil' Drug Store® logo]

PDP/PackagePDP/Package

Mucinex ® DM 2ct, TRAVEL BASIX - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucinex ® DM

600 mg guaifenesin & 30 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPEXTORANT & COUGH SUPPRESSANT

12

HOUR

[tablet image]

[check mark] Controls Cough

[check mark] Thins and Loosens Mucus

[check mark] Immediate and Extended release

2

EXTENDED-RELEASE

BI-LAYER TABLETS

[TRAVEL BASIX logo]

PDP/PackagePDP/Package®

Mucinex ® DM 2ct CVP ® HEALTH - PDPPackage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mucinex ® DM

600 mg guaifenesin & 30 mg dextromethorphan HBr

extended-release bi-layer tablets

EXPEXTORANT & COUGH SUPPRESSANT

12

HOUR

[tablet image]

[check mark] Controls Cough

[check mark] Thins and Loosens Mucus

[check mark] Immediate and Extended release

2

EXTENDED-RELEASE

BI-LAYER TABLETS

[CVP ® HEALTH logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN8
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD8
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6424-1Mucinex DM, TRAVEL BASIX2 in 1 POUCHTABLET, EXTENDED RELEASE28
66715-6424-1Mucinex DM, TRAVEL BASIX1 in 1 CARTONTABLET, EXTENDED RELEASE18
66715-6524-1Mucinex DM, CVP HEALTH1 in 1 CARTONTABLET, EXTENDED RELEASE18
66715-6524-1Mucinex DM, CVP HEALTH2 in 1 POUCHTABLET, EXTENDED RELEASE28
66715-9724-1Mucinex DM1 in 1 CARTONTABLET, EXTENDED RELEASE18
66715-9724-1Mucinex DM2 in 1 POUCHTABLET, EXTENDED RELEASE28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6424MUCINEX DM, CVP HEALTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM, TRAVEL BASIX (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, 2 package rows20231011_c274b05c-8f05-4980-9a93-77affb322e57.zip
66715-6524MUCINEX DM, CVP HEALTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM, TRAVEL BASIX (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, 2 package rows20231011_c274b05c-8f05-4980-9a93-77affb322e57.zip
66715-9724MUCINEX DM, CVP HEALTH (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM, TRAVEL BASIX (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EXTENDED RELEASE [LIL' DRUG STORE PRODUCTS, INC.]8Current NDC, Legacy NDC, 2 package rows20231011_c274b05c-8f05-4980-9a93-77affb322e57.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH2
GuaifenesinACTIVE INGREDIENT495W7451VQ2
DextromethorphanACTIVE MOIETY7355X3ROTS2
GuaifenesinACTIVE MOIETY495W7451VQ2
aluminum oxideINACTIVE INGREDIENTLMI26O69332
carbomer homopolymer type B (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTHHT01ZNK312
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3G2
hypromellosesINACTIVE INGREDIENT3NXW29V3WO2
magnesium stearateINACTIVE INGREDIENT70097M6I302

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-652466715-6524-1
66715-642466715-6424-1
66715-972466715-9724-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C yellow no. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, EXTENDED RELEASE / ORAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
carbomer homopolymer type B (allyl pentaerythritol crosslinked)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET, EXTENDED RELEASE / ORAL180 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
aluminum oxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
6 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii+route+dosage form
6 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021620-001MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29
N021620-002MUCINEX DMDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29c2088c7a36db…
2026-10-15 13:18:302026-09N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29c2088c7a36db…
2026-09-14 22:38:342026-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2984e616aacf4f…
2026-08-18 06:07:402026-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021620-001MUCINEX DM60MG;1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2004-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021620-002MUCINEX DM30MG;600MGTABLET, EXTENDED RELEASE / ORALRLD2004-04-294b0b4de00fa7…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021620-00163722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00169558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00263722522020-04-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00269558212020-04-28U-685Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021620-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021620-00163722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00169558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00263722522020-04-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00269558212020-04-28U-685Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021620-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021620-00163722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00169558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00263722522020-04-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00269558212020-04-28U-685Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021620-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021620-00163722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00169558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00263722522020-04-28Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00269558212020-04-28U-685Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021620-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021620-00163722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00169558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00263722522020-04-28Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00269558212020-04-28U-685Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021620-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021620-00163722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00169558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00263722522020-04-28Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00269558212020-04-28U-685Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021620-00278380322020-04-28Drug productea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex DM, TRAVEL BASIXGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDELil' Drug Store Products, Inc.c274b05c-8f05-4980-9a93-77affb322e572023-10-10WarningsExact identifier
ndc (package): 66715-6424-1
ndc (package): 66715-9724-1
ndc (package): 66715-6524-1
ndc (product): 66715-6524
ndc (product): 66715-6424
ndc (product): 66715-9724
ndc11 (package): 66715642401
ndc11 (package): 66715652401
ndc11 (package): 66715972401
spl id: 075d4215-dba2-3d49-e063-6394a90a1e25
spl set id: c274b05c-8f05-4980-9a93-77affb322e57

Reported adverse events (FAERS/openFDA)#

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