FDA.reportPublic FDA data

CVS Nighttime Cold and Flu Relief

Product NDC
51316-692
11-digit product format
513160692
Labeler code
51316
Product ID
51316-692_8a9c5ccb-85c9-4ec4-ac3a-f42b27856cc7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS PHARMACY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-13
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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
CVS Nighttime Cold and Flu Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
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
1043400Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-692-12CVS Nighttime Cold and Flu Relief354 mL in 1 BOTTLESOLUTION3545

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-692CVS NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4Current NDC, 1 package rows20240821_87d4cfc0-c7b4-42c0-bfa9-96e124e32ed3.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 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEWALGREEN COMPANYe96ec4d4-53b9-4636-a58c-1a5923a021ad2025-10-31WarningsExact identifier
application number: M010
GOODNOW SLEEP AIDDIPHENHYDRAMINE HCLGobrands, Inc7d821b7d-6a31-4ff7-b587-51907ba626582025-10-29WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDEMedtech Products Inc.f7858ecf-8498-4465-85d8-3e78147375732025-10-23WarningsExact identifier
application number: M010
Sominex MaxDIPHENHYDRAMINE HCLMedtech Products Inc.e8f6991f-c47a-4d12-934b-04fdf092dac32025-10-23WarningsExact identifier
application number: M010
equate NIGHTTIME Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.3d3f2e0c-e141-d49f-e063-6394a90ad0e62025-10-21WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH6fe34d05-84a4-4254-aea6-77b52122ea182025-10-14WarningsExact identifier
application number: M010
LEADER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDECARDINAL HEALTH68c79c47-11bf-4b51-ace0-723cac7a46202025-10-14WarningsExact identifier
application number: M010
InstaRelief Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEDXM Pharmacuetical, Inc.e0459e71-32dd-4715-b103-bb14db42c5f32025-10-06WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)1eb2e4d7-1572-4c0c-888b-342831298cad2025-10-03WarningsExact identifier
application number: M010
AXIV - VroZzzDIPHENHYDRAMINE HYDROCHLORIDEVivunt Pharma LLC131a60cf-02ec-5a5b-e063-6294a90abd1f2025-09-17WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)485ce8ae-c2b7-462f-9c08-8594cd121f0c2025-09-11WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEWALGREENS35b78063-e717-2ccb-e063-6394a90a18eb2025-09-04WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationded84160-8f6a-4ad1-93be-efbf3a6c3b8f2025-09-03WarningsExact identifier
application number: M010
QUALITY CHOICE NIGHTTIME SLEEP AIDDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)3ce00c99-1a9b-41f1-a99a-35e03730dff02025-08-23WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f476647-5727-3443-e063-6394a90afd3f2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f477706-0ce2-97b0-e063-6294a90a5c8e2025-08-19WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health407ff0ee-41a3-4dea-95c8-556f664e115e2025-08-06WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLH E B1069961c-ed3b-471f-a632-81024c37dbd92025-08-04WarningsExact identifier
application number: M010
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC2ea0b2cf-f055-11f6-e063-6394a90a53642025-08-01WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLGood Sense (Geiss, Destin & Dunn, Inc.)135482d0-5264-4c81-b43b-8fc931bb02e82025-07-30WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN87d4cfc0-c7b4-42c0-bfa9-96e124e32ed35
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD87d4cfc0-c7b4-42c0-bfa9-96e124e32ed35
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed35
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed35
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY87d4cfc0-c7b4-42c0-bfa9-96e124e32ed35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-692-1251316069212354 mL in 1 BOTTLE (51316-692-12) 354 ml2023-02-13NoNoCurrent