FDA.reportPublic FDA data

NIGHTTIME COUGH DM

Product NDC
51316-791
11-digit product format
513160791
Labeler code
51316
Product ID
51316-791_97e8504a-79e5-490f-8ae5-af970491af33
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-24
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
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
NIGHTTIME COUGH DM
Listing expiration
2027-12-31

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
646f65f4-b9e4-4291-aadc-d2070848d35cAvailable on FDA.report

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 132 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3ef6d155-b95b-4b30-87a8-8ed811b1520f2024-12-03WarningsExact identifier
application number: M012
Sinus plus HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b2b16d-c767-2945-e053-2995a90a48342024-12-03WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCarefa9b2748-0474-4a39-a2b8-bb6f0678c1d12024-12-03WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa9640e09-369c-3c55-e053-2a95a90aebd52024-12-03WarningsExact identifier
application number: M012
Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c7-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
COLD AND FLU SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREcbb179c8-31fb-4a3a-9f23-4024350f8b7f2024-12-03WarningsExact identifier
application number: M012
Allergy Multi SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCa96431a0-b05d-4812-e053-2a95a90a5af62024-12-03WarningsExact identifier
application number: M012
Cold Max NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCaa0d6762-b803-4630-8f74-780b7ea9acff2024-12-03WarningsExact identifier
application number: M012
Cold plus Head CongestionACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCec7e5e2e-23c5-32ae-e053-2995a90a12512024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC898eb1c7-395a-4845-9d0a-719fc78d86b72024-12-03WarningsExact identifier
application number: M012
Cold Plus Head Congestion NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC7854c1fd-b5fc-477d-a79e-ff006ebf6fe52024-12-03WarningsExact identifier
application number: M012
Cold and Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLCe07d880b-a12a-4e5e-94c0-bd36bcfe738c2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREbd0a3679-1f7c-4c41-e053-2995a90a8fcb2024-12-03WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCbd09e4f3-3211-8c08-e053-2a95a90a73f92024-12-03WarningsExact identifier
application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HClACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLCb373a3a8-68c4-0187-e053-2995a90aad622024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold and Flu All In OneACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCAREa1b281ec-fd42-963c-e053-2a95a90a4b712024-12-03WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETOPCO ASSOCIATES LLCb3366ad4-5ef4-eb70-e053-2995a90acf332024-12-03WarningsExact identifier
application number: M012
Meijer Medicated Chest Rub, 3.53 oz. LavenderMENTHOL, CAMPHOR, EUCALYPTUS OILMeijer Distribution22516f25-b8aa-7511-e063-6394a90a61252024-12-03WarningsExact identifier
application number: M012
Tenalif ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd9513-1a42-e990-e063-6294a90a57df2024-12-03WarningsExact identifier
application number: M012
Tenalif Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cd94e7-1808-3bb3-e063-6294a90a41402024-12-03WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-791-26513160791261 BOTTLE in 1 CARTON (51316-791-26) / 118 mL in 1 BOTTLE (51316-791-00) 1 bottle2026-06-24NoNoCurrent