Childrens Pain Relief

Product NDC
68016-725
11-digit product format
680160725
Labeler code
68016
Product ID
68016-725_51a5bb5a-ab79-4cf4-bbf6-95c33cd6d6af
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-30
Marketing end
2022-07-22
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-725DDiscontinued by firm2026-10-05
excluded packagepackage68016-72568016-725-04DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-725-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-725-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-725-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-725-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-725-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-725-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-725-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-725-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-725-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-725-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-725-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-725-04557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-725-04ML - Milliliter68016-72594a43325-d659-4b73-abbe-c8f93c445fff12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
CHERRYINACTIVE INGREDIENTBUC5I9595WCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [CHAIN DRUG CONSORTIUM, LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-725-04680160725041 BOTTLE in 1 CARTON (68016-725-04) > 118 mL in 1 BOTTLE1 bottle2015-04-302022-07-22NoNoCurrent