Pain Away plus Sleep aid

Product NDC
68016-730
11-digit product format
680160730
Labeler code
68016
Product ID
68016-730_1fb56ce7-97a2-4384-b027-45e86f43f3c5
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-07-24
Marketing end
2022-07-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/15mL; mg/15mL
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 productproduct68016-730DDiscontinued by firm2026-10-12
excluded packagepackage68016-73068016-730-08DDiscontinued by firm2026-10-12

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 packagepackage68016-730-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-730-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-730-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-730-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-730-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-730-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-730-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-730-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-730-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-730-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-730-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-730-08557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
BERRYINACTIVE INGREDIENTFV3431923ZPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN AWAY PLUS SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [CHAIN DRUG CONSORTIUM, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-730-08680160730081 BOTTLE in 1 CARTON (68016-730-08) > 237 mL in 1 BOTTLE1 bottle2015-07-242022-07-01NoNoCurrent