FDA.reportPublic FDA data

CVS Childrens Nighttime Multi Symptom Cold

Product NDC
51316-733
11-digit product format
513160733
Labeler code
51316
Product ID
51316-733_e1d05e87-3e21-4047-a40e-99af2d87282d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen , Diphenhydramine Hydrochloride,Phenylephrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
CVS PHARMACY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-20
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
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 Childrens Nighttime Multi Symptom Cold
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1375932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b244ac8-4ca7-43a0-b328-88f15f0fcc9dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-733-04CVS Childrens Nighttime Multi Symptom Cold118 mL in 1 BOTTLELIQUID1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-733CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD (ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CVS PHARMACY]4Current NDC, 1 package rows20240822_9b244ac8-4ca7-43a0-b328-88f15f0fcc9d.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
1375932acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral SolutionPSN9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral SolutionSY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral SolutionSY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5
1375932APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral SolutionSY9b244ac8-4ca7-43a0-b328-88f15f0fcc9d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-733-0451316073304118 mL in 1 BOTTLE (51316-733-04) 118 ml2023-02-20NoNoCurrent