FDA.reportPublic FDA data

Childrens Pain Relief

Product NDC
37808-482
11-digit product format
378080482
Labeler code
37808
Product ID
37808-482_b4de4354-f780-4447-b679-19bc4a5c067f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-08
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 Relief
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
a0c0277e-50aa-4328-8f93-ab20c6176b2bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-482-042023-02-15C16284748780-1f386c649-e78d-0266-e053-dadaa90a7c1aDrug Facts
37808-482-042023-01-30C16284748780-1f386c649-e78d-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-482-04Childrens Pain Relief118 mL in 1 BOTTLE, PLASTICSUSPENSION1187
37808-482-04Childrens Pain Relief1 in 1 BOXSUSPENSION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-482CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [H E B]7Current NDC, Legacy NDC, 2 package rows20240404_a0c0277e-50aa-4328-8f93-ab20c6176b2b.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 12 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutions92559d65-f5e2-4054-9763-b9c560452dab2026-05-22WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.441d2629-3fff-0bf1-e063-6394a90aa9b62026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d1bde-d677-fab7-e063-6394a90aaad42026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d3a39-cc55-3c7c-e063-6394a90ad7a72026-05-21WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
application number: M013
Good Sense aspirinASPIRINL. Perrigo Companye150dd59-8db8-449f-9c9a-1aa6deb3be2e2026-05-20WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLCe837538d-0515-4f99-b04c-fda63b28777e2026-05-20WarningsExact identifier
application number: M013
Walgreens Headache Relief Extra StrengthACETAMINOPHEN 250MG, ASPIRIN 250MG AND CAFFEINE 65MGWalgreens52109b65-3bf1-de38-e063-6394a90a97272026-05-18WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.5220a40d-4a4f-5bad-e063-6394a90a93b02026-05-18WarningsExact identifier
application number: M013
childrens Pain and FeverACETAMINOPHENTopco Associates, LLC7f7b4377-9b40-4a12-808b-f1cd7d241b0d2026-05-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINGendose Pharmaceuticals, LLC10b9a1fc-70d1-44ea-a6de-5c1943e8fbaa2026-05-15WarningsExact identifier
application number: M013
AspirinASPIRINGendose Pharmaceuticals, LLC119de26f-cce5-401c-81fa-775ebebf6c6f2026-05-15WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINCardinal Health 107, LLC827bbe77-febb-4352-892f-3fbb2acfc7d52026-05-14WarningsExact identifier
application number: M013
AspirinASPIRINTopco Associates, LLC56c125de-fabf-41fa-88a4-760d2793f2022026-05-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEChain Drug Marketing Association, Inc.17216bf3-bed0-4d7a-994e-76a0e4c79c5c2026-05-13WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutionsc445c6bb-69a8-492e-b100-ce942707f2032026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Company1754a9f2-e7e5-4efb-a728-6ba2a7155d112026-05-12WarningsExact identifier
application number: M013
Menstrual ReliefACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATETarget Corporationbc65e205-64fd-4764-8c5e-2793af4e9adf2026-05-12WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLCa7e27000-a26b-46c2-823e-663f4e76db742026-05-11WarningsExact identifier
application number: M013
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 32 MG/ML Oral SuspensionSCDa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7
307668APAP 32 MG/ML Oral SuspensionSYa0c0277e-50aa-4328-8f93-ab20c6176b2b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-482-04378080482041 BOTTLE, PLASTIC in 1 BOX (37808-482-04) / 118 mL in 1 BOTTLE, PLASTIC2015-03-080000-00-00NoNoCurrent