FDA.reportPublic FDA data

childrens acetaminophen

Product NDC
41163-045
11-digit product format
411630045
Labeler code
41163
Product ID
41163-045_4f6173e2-62ad-4e56-b04e-caec9a6c567d
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-02-25
Substance
ACETAMINOPHEN
Active strength
160 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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 acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/1

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
313820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f65203a2-64f0-4138-97e4-6eab99194178Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-045-08childrens acetaminophen4 in 1 CARTONTABLET, CHEWABLE412
41163-045-08childrens acetaminophen6 in 1 BLISTER PACKTABLET, CHEWABLE612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-045CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI]11Current NDC, Legacy NDC, 2 package rows20241222_f65203a2-64f0-4138-97e4-6eab99194178.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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
application number: M013
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
application number: M013
Meijer Effervescent Pain ReliefASPIRINMeijer Distribution Inc17553911-e0fc-e355-e063-6394a90af7b82024-06-28WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsExact identifier
application number: M013
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsExact identifier
application number: M013
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
application number: M013
AspirinREGULAR STRENGTH ENTERIC COATED ASPIRINNuCare Pharmceuticals,Inc.a0705f4f-55cb-214a-e053-2995a90aa6802024-06-20WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRETAIL BUSINESS SERVICES , LLC.093182a6-3ed8-5a3f-e063-6294a90a354a2024-06-14WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNf65203a2-64f0-4138-97e4-6eab9919417812
313820acetaminophen 160 MG Chewable TabletSCDf65203a2-64f0-4138-97e4-6eab9919417812
313820APAP 160 MG Chewable TabletSYf65203a2-64f0-4138-97e4-6eab9919417812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-045-08411630045084 BLISTER PACK in 1 CARTON (41163-045-08) / 6 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2005-02-250000-00-00NoNoCurrent