FDA.reportPublic FDA data

Childrens Pain Relief

Product NDC
63868-176
Requested package NDC
63868-176-26
11-digit product format
638680176
Labeler code
63868
Product ID
63868-176_f04fffc2-5b25-4e5e-bb8a-9d9ea703c097
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage63868-17663868-176-26DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-176-262023-04-27C16284748780-1f386c649-eb1d-0266-e053-dadaa90a7c1aDrug Facts
63868-176-262023-01-30C16284748780-1f386c649-eb1d-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-176-26ML - Milliliter63868-17646f6666d-d1fd-4d97-aa3f-806926e1ee2012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-176-26638680176261 BOTTLE in 1 BOX (63868-176-26) > 118 mL in 1 BOTTLE1 bottle2015-04-300000-00-00NoNoCurrent