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 79 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Sore Throat LozengeBENZOCAINEAmerican Sales49248a40-1ca3-6dd1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLAmerican Sales4896cbd1-57dd-1fc6-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact 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