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 116 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCVS Pharmacy70914691-220c-4fce-9ee1-61a51e8864bc2025-04-26WarningsExact identifier
application number: M012
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B5f945975-224f-43eb-b129-a61e3b25c4bb2025-04-22WarningsExact identifier
application number: M012
Walgreens Severe Honey Lemon Throat DropsMENTHOLWalgreens334a9348-2a44-5c94-e063-6394a90ae9562025-04-21WarningsExact identifier
application number: M012
meijer Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bd85bc3-e600-583d-e063-6294a90a7be12025-04-18WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKROGER COMPANY2be4a37b-44e1-8a8e-e063-6394a90a26a92025-04-17WarningsExact identifier
application number: M012
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC729ab412-f30b-4ad1-9d8f-1a5e1c48b1182025-04-16WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9382c976-3067-4923-a38f-101d1c481e972025-04-11WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULESWalmart Inc.263d31c8-bdc2-a289-e063-6394a90a4aaa2025-04-10WarningsExact identifier
application number: M012
CVS Wild Cherry Throat DropPECTINCVS31f4b641-e9c0-786e-e063-6394a90aa2532025-04-04WarningsExact identifier
application number: M012
Nighttime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOFTGELSWALGREENS2be0a699-e6ad-ef56-e063-6394a90aaca52025-04-03WarningsExact identifier
application number: M012
Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED44fb27d3-5125-4511-84d2-76555bc46e662025-04-03WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION31b8ad0a-3637-03db-e063-6394a90acdc32025-04-01WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp31aa54d8-df8d-f1ae-e063-6294a90a96222025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINBryant Ranch Prepack570a71eb-2d19-4c7b-8c00-e1524bfa38442025-03-31WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINKESIN PHARMA CORPORATION365c01b7-a197-4876-85fc-42204f787e3a2025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLBryant Ranch Prepack59aeb692-2f79-45aa-8e6a-dab77cd3b2f92025-03-28WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEOncor Pharmaceuticals06ecba97-c790-4672-a8c3-f9caf6272d262025-03-27WarningsExact 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