FDA.reportPublic FDA data

topcare tussin dm max

Product NDC
36800-788
11-digit product format
368000788
Labeler code
36800
Product ID
36800-788_cbbc011d-affa-4a54-876d-c77175eca749
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Topco Associates LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-02
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
2026-12-31
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
topcare tussin dm max
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1118592-30ac-4505-9f38-c6d395c4cf5bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-788-26topcare tussin dm max118 mL in 1 BOTTLESOLUTION1184
36800-788-26topcare tussin dm max1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-788TOPCARE TUSSIN DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20241113_e1118592-30ac-4505-9f38-c6d395c4cf5b.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 87 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ctMENTHOLRiclan S.A.0f0260df-89ac-4b83-afea-3aff56ff1b432025-11-18WarningsExact identifier
application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ctMENTHOLRiclan S.A.16f6d531-9298-4172-8d08-ecd87d6add762025-11-18WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCa6f750c8-8738-4965-a3ad-612c246110562025-11-18WarningsExact identifier
application number: M012
YINCHIAOACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.09ba45f6-03e1-46b9-83ab-a618b26267162025-11-18WarningsExact identifier
application number: M012
GANMAOLINGACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.c757a03e-59ea-469c-970d-4bc62e73f36f2025-11-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepacke1d545dc-9222-4d61-964d-1c781215d7d22025-11-18WarningsExact identifier
application number: M012
Goodnow cold flu day relief cold flu night reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGobrands, Inc7590d0c6-121e-4016-b6bb-534c5d0a79702025-11-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDER J General Corporationd786ae07-ce57-44c7-9ba5-f4c87df115de2025-11-17WarningsExact identifier
application number: M012
Benadryl AllergyDIPHENHYDRAMINE HYDROCHLORIDER J General Corporationc46c01c0-29f4-400c-bef5-14b3eb944c512025-11-17WarningsExact identifier
application number: M012
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
application number: M012
TYLENOL SINUS SEVEREACETAMINOPHENR J General Corporation2cbf7954-b28f-4d7b-b142-6c6c5c58b25d2025-11-17WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRR J General Corporation8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2025-11-17WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQUALITY CHOICE (Chain Drug Marketing Association)c0e3c959-bed6-2ce5-e053-2995a90a0be92025-11-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpc5ea5a7a-c806-e5e0-e053-2995a90a15e92025-11-17WarningsExact identifier
application number: M012
Multi-Symptom Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED50f3157b-5788-4b63-835a-e60c8dc33df92025-11-17WarningsExact identifier
application number: M012
Day and Night SinusACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inca9d809f5-63a1-4f80-8b4d-33e8e052c7bd2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company937b481a-e0b7-4d34-a8a1-0bfb2b867c2b2025-11-15WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.f701a6ae-200d-48dc-94e4-6bd3228f50d42025-11-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNe1118592-30ac-4505-9f38-c6d395c4cf5b4
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDe1118592-30ac-4505-9f38-c6d395c4cf5b4
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYe1118592-30ac-4505-9f38-c6d395c4cf5b4
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYe1118592-30ac-4505-9f38-c6d395c4cf5b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-788-26368000788261 BOTTLE in 1 CARTON (36800-788-26) / 118 mL in 1 BOTTLE1 bottle2019-05-020000-00-00NoNoCurrent