FDA.reportPublic FDA data

CVS Nighttime Childrens

Product NDC
51316-752
11-digit product format
513160752
Labeler code
51316
Product ID
51316-752_cf993198-8b96-4dec-9658-927875ca5b43
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate and Dextromethorphan Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS PHARMACY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-20
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2; 15 mg/15mL; mg/15mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 Childrens
Brand name suffix
Cold and Cough Multi-Symptom Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE15 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114361Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d66b1a2e-49b6-473b-acec-2694c73ce8b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-752-08CVS Nighttime ChildrensCold and Cough Multi-Symptom Relief236 mL in 1 BOTTLE, PLASTICSOLUTION2365

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-752CVS NIGHTTIME CHILDRENS COLD AND COUGH MULTI-SYMPTOM RELIEF (CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [CVS PHARMACY]4Current NDC, 1 package rows20240823_d66b1a2e-49b6-473b-acec-2694c73ce8b4.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 11 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDIPHENHYDRAMINE HCLH E Bd5189048-5eed-4ec4-8c4a-4a167728c4e72024-10-16WarningsExact identifier
application number: M010
berkley and jensen sleep aidDIPHENHYDRAMINE HCLBJWCe31917a1-e72d-4f71-893f-43046169a32d2024-10-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association5fab9bd4-66d7-4356-a778-8900b2e270e22024-10-11WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)5b005bfc-f588-4abc-8bb1-4691b40448cd2024-10-07WarningsExact identifier
application number: M010
SominexDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.f70ce1a6-c334-025e-e053-6294a90ae53f2024-10-03WarningsExact identifier
application number: M010
meijer NIGHTTIME Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1c2b57b3-92cb-256b-e063-6394a90ad41b2024-09-09WarningsExact identifier
application number: M010
Up and Up Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation0ab5a374-d565-4385-bee3-538a8f09b19e2024-08-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.8d985ad7-71b9-493f-9b9a-d6ef280f72dd2024-08-12WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3618eb73-6929-4ca5-833d-265b006f15f92024-08-12WarningsExact identifier
application number: M010
careone nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEAmerican Sales Company14803f99-52c7-4324-b64c-9719061447392024-07-17WarningsExact identifier
application number: M010
Betr sleep aidDIPHENHYDRAMINE HYDROCHLORIDELive Betr LLC8c2d5514-62c1-4e98-8412-20534365b9342024-07-17WarningsExact identifier
application number: M010
topcare sleep aid nighttimeDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC30284271-0411-4abf-bc62-d956dc7944322024-07-17WarningsExact identifier
application number: M010
dg health sleep aidDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp Inc038c1b4e-43f5-4370-896b-97da1b0a89ca2024-07-17WarningsExact identifier
application number: M010
good sense nighttime sleep aidDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Companyba2adc30-0301-4d53-bce6-fc8b7e34b0762024-07-10WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDGood Sensec1481fad-9b32-4f84-8f03-4b4fa5edc8662024-06-18WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)29b49616-ee5a-4574-81f1-0052addb8f662024-04-22WarningsExact identifier
application number: M010
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b8757d18-6c7d-45de-925a-e2814625f7492024-04-22WarningsExact identifier
application number: M010
EZ Nite SleepDIPHENHYRAMINE HYDROCHLORIDEKROGER COMPANY0fec16a4-b4eb-8f8f-e063-6394a90a73272024-04-17WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLCVS Pharmacydb951d14-ba8b-4d56-8264-2b8ce84a854c2024-03-07WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)e0da439f-7e23-4e60-8d16-b607aa41ed172024-02-28WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114361chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSNd66b1a2e-49b6-473b-acec-2694c73ce8b45
1114361chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCDd66b1a2e-49b6-473b-acec-2694c73ce8b45
1114361chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSYd66b1a2e-49b6-473b-acec-2694c73ce8b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-752-0851316075208236 mL in 1 BOTTLE, PLASTIC (51316-752-08) 236 ml2023-02-20NoNoCurrent