FDA.reportPublic FDA data

Mucus Relief DM

Product NDC
55301-533
11-digit product format
553010533
Labeler code
55301
Product ID
55301-533_d4ba3d94-4525-4051-8b7a-8589de29990f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Mucus Relief DM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc0a3761-bbe2-4261-a183-594f5fb12b0bAvailable on FDA.report

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
55301-533-01Mucus Relief DM10 in 1 BLISTER PACKTABLET, FILM COATED1014
55301-533-01Mucus Relief DM3 in 1 CARTONTABLET, FILM COATED314

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
GUAIFENESINACTIVE INGREDIENT495W7451VQMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
GUAIFENESINACTIVE MOIETY495W7451VQMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-533MUCUS RELIEF DM (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE]13Current NDC, Legacy NDC, 2 package rows20241024_dc0a3761-bbe2-4261-a183-594f5fb12b0b.zip

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 62 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
application number: M012
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLJC SALES490b2d1e-3a1d-1a52-e063-6394a90a00ba2026-01-01WarningsExact identifier
application number: M012
NUVALU VAPORIZING CHEST RUBCAMPHOR, EUCALYPTUS OIL, MENTHOLNingbo Liyuan Daily Chemical Products Co., Ltd.4947540b-73c9-d44a-e063-6294a90a9d372026-01-01WarningsExact identifier
application number: M012
PANCOLD AACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUSDONGWHA PHARM. CO. LTD.fc8f1807-d344-ccc2-e053-6294a90a50892025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSNdc0a3761-bbe2-4261-a183-594f5fb12b0b14
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCDdc0a3761-bbe2-4261-a183-594f5fb12b0b14
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSYdc0a3761-bbe2-4261-a183-594f5fb12b0b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-533-01553010533013 BLISTER PACK in 1 CARTON (55301-533-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2005-12-310000-00-00NoNoCurrent