Pain Reliever PM

Product NDC
15127-325
Requested package NDC
15127-325-24
11-digit product format
151270325
Labeler code
15127
Product ID
15127-325_0bf8ca36-73bc-4a32-9eda-6e7bf1f41180
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L&R Distributors, Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1994-05-15
Marketing end
2021-09-10
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
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 packagepackage15127-32515127-325-24DDiscontinued 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 · 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15127-325-24EA - Each15127-3251a88c563-d513-4db1-9f31-53da1220be1a12012-07-24
15127-325-50EA - Each15127-325ccbcdf51-bd2d-4761-9847-10f3c28c5df812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [STEPHEN L. LAFRANCE PHARMACY, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
15127-325-24151270325241 BOTTLE, PLASTIC in 1 CARTON (15127-325-24) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1994-05-152021-09-10NoNoCurrent