Rugby Acetaminophen 500 mg and

Product NDC
0536-1015
11-digit product format
005361015
Labeler code
0536
Product ID
0536-1015_7f6b5c77-4f22-7e40-e053-2a91aa0a00c3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-08-26
Marketing end
2020-10-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-1015DDiscontinued by firm2026-10-12
excluded packagepackage0536-10150536-1015-06DDiscontinued 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 packagepackage0536-1015-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-1015-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-1015-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-1015-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-1015-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-1015-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-1015-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-1015-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-1015-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-1015-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-1015-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-1015-06557ba5c1ecfa…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
0536-1015-06EA - Each0536-1015634d99de-bbc5-419b-934e-33189433737a12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ERUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG PAIN RELIEVER/SLEEP AID (ACETAMINOPHEN,DIPHENHYDRAMINE HCL) TABLET, FILM COATED [RUGBY LABORATORIES]3