FDA.reportPublic FDA data

childrens acetaminophen

Product NDC
41163-045
Requested package NDC
41163-045-08
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 49 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENMajor Pharmaceuticals38b839b6-de7d-4f33-a19a-efc92cdad92c2025-01-24WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
application number: M013
Safety Coated Aspirin 81 mg Low DoseASPIRIN 81MGUlai Health LLC3d225a11-a53b-4dc2-9c25-13cab007900f2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCc9d3cee1-531c-439f-ae19-07acd366aad62025-01-20WarningsExact identifier
application number: M013
Percogesic Original StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLMedtech Products Inc.529974c2-0121-4892-8e47-c2c4475810912025-01-17WarningsExact identifier
application number: M013
Little Remedies Childrens Fever Pain RelieverACETAMINOPHENMedtech Products Inc.e1e44c85-d10c-4997-8f85-064cda7906eb2025-01-17WarningsExact identifier
application number: M013
StanbackASPIRIN AND CAFFEINEMedtech Products Inc.caaa1313-09e4-45aa-8836-346f6a3701962025-01-17WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPrecision Dose Inc.5cc698fa-0841-4851-ae21-0aac8b40eb0a2025-01-16WarningsExact identifier
application number: M013
EcotrinASPIRINMedtech Products Inc.222d187b-aae6-410b-baeb-b2bd42f5c6762025-01-16WarningsExact identifier
application number: M013
Children Pain and Fever RelieverACETAMINOPHENTarget Corporation0dd643a4-3cbc-423d-95b4-ba373b09d8952025-01-16WarningsExact identifier
application number: M013
Chewable Low Dose AspirinASPIRINTARGET CORPORATIONf934e72a-2e9f-da17-e053-6394a90a1a2e2025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENReliable 1 Laboratories LLC2651bf11-4d66-43ba-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINReliable 1 Laboratories LLC2ab8564f-f958-7512-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENReliable 1 Laboratories LLC25626b46-78f8-7226-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINReliable 1 Laboratories LLCb247fe39-7f65-e502-e053-2a95a90a08f12025-01-15WarningsExact identifier
application number: M013
PharbetolACETAMINOPHEN 500MGUlai Health LLCe64ce7b1-4501-4b51-b012-1882ed153b422025-01-13WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRIN 325MGUlai Health LLC26942d32-d6e6-464d-8fc4-ffd9806d3e622025-01-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENWAL-MART STORES INCa354b24e-0913-829f-e053-2995a90ad4072025-01-11WarningsExact 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