Adult Pain Reliever/Fever Reducer

Product NDC
68016-166
11-digit product format
680160166
Labeler code
68016
Product ID
68016-166_5c051a58-3fd0-49b0-abee-570425e6ae9b
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-05-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/15mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-166DDiscontinued by firm2026-10-20
excluded packagepackage68016-16668016-166-08DDiscontinued by firm2026-10-20

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 packagepackage68016-166-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-166-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-166-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-166-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-166-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-166-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-166-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-166-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-166-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-166-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-166-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-166-08557ba5c1ecfa…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
68016-166-08ML - Milliliter68016-166041c2356-0708-4977-b8df-bd39d48ea27d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
CHERRYINACTIVE INGREDIENTBUC5I9595WADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RADULT PAIN RELIEVER/FEVER REDUCER (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1