FDA.reportPublic FDA data

Non-Aspirin

Product NDC
63868-186
Requested package NDC
63868-186-24
11-digit product format
638680186
Labeler code
63868
Product ID
63868-186_c50b00c2-765c-46f2-b2bd-607f4b84742b
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2005-01-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-18663868-186-24DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
63868-186-24Non-Aspirinchildrens24 in 1 BOTTLETABLET, CHEWABLE2412
63868-186-24Non-Aspirinchildrens1 in 1 CARTONTABLET, CHEWABLE112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-186-24EA - Each63868-18659e6b0a3-7621-4e51-b715-8cd3a1f36ac112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-186NON-ASPIRIN CHILDRENS (ACETAMINOPHEN) TABLET, CHEWABLE [CHAIN DRUG MARKETING ASSOCIATION INC]10Legacy NDC, 2 package rows20240825_ea786813-87ee-441d-815b-352aa126744a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Aspirin childrensACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INCea786813-87ee-441d-815b-352aa126744a2025-08-26WarningsExact identifier
ndc (package): 63868-186-24
ndc (product): 63868-186
ndc11 (package): 63868018624

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313820acetaminophen 160 MG Chewable TabletPSNea786813-87ee-441d-815b-352aa126744a12
313820acetaminophen 160 MG Chewable TabletSCDea786813-87ee-441d-815b-352aa126744a12
313820APAP 160 MG Chewable TabletSYea786813-87ee-441d-815b-352aa126744a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-186-24638680186241 BOTTLE in 1 CARTON (63868-186-24) > 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2005-01-280000-00-00NoNoCurrent