Pain Relief PM

Product NDC
55319-998
Requested package NDC
55319-998-20
11-digit product format
553190998
Labeler code
55319
Product ID
55319-998_23224b18-1c98-4bdb-9e7e-9339406079d9
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-23
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55319-99855319-998-20DDiscontinued 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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
BERRYINACTIVE INGREDIENTFV3431923ZPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3APAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4PAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEF PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [FAMILY DOLLAR, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-998-20553190998201 BOTTLE in 1 CARTON (55319-998-20) > 237 mL in 1 BOTTLE1 bottle2015-06-232022-07-01NoNoCurrent