FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
51316-098
11-digit product format
513160098
Labeler code
51316
Product ID
51316-098_dc7442bd-8264-4b7a-a069-5c2d28e68e90
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-05
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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
Childrens Pain and Fever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d96a1531-772b-4a5c-89e4-66fff1fa3d78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-098-19Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-19Childrens Pain and Fever237 mL in 1 BOTTLE, PLASTICSUSPENSION2376
51316-098-36Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-36Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-098CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]4Current NDC, 4 package rows20240829_d96a1531-772b-4a5c-89e4-66fff1fa3d78.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 67 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low doseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.bfb9af64-3195-44bf-bcf3-6b36b40d3cc72024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.609948d6-0f20-4d0c-adc0-6ae72a4f2b7a2024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.3f73a359-59d7-47bb-872e-914b0db719af2024-06-13WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013
Cafiaspirina Rapid Headache ReliefASPIRIN, CAFFEINEBelmora LLCd890acec-6528-4fb7-8d59-6c572a3f07862024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 32 MG/ML Oral SuspensionSCDd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786
307668APAP 32 MG/ML Oral SuspensionSYd96a1531-772b-4a5c-89e4-66fff1fa3d786

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-098-19513160098191 BOTTLE, PLASTIC in 1 CARTON (51316-098-19) / 237 mL in 1 BOTTLE, PLASTIC2024-04-05NoNoCurrent
51316-098-36513160098361 BOTTLE, PLASTIC in 1 CARTON (51316-098-36) / 118 mL in 1 BOTTLE, PLASTIC2024-04-05NoNoCurrent