Percogesic Original Strength

Product NDC
63029-050
Requested package NDC
63029-050-24
11-digit product format
630290050
Labeler code
63029
Product ID
63029-050_d89d64f1-0b97-46d8-96f1-516792498a32
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Medtech Products Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-03-19
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE
Active strength
325 mg/1; mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63029-05063029-050-24DDiscontinued by firm2026-10-16

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 INGREDIENT362O9ITL9DPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
DIPHENHYDRAMINEACTIVE INGREDIENT8GTS82S83MPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPERCOGESIC ORIGINAL STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) TABLET, COATED [MEDTECH PRODUCTS INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-050-24630290050241 BOTTLE, PLASTIC in 1 BOX (63029-050-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2010-03-190000-00-00NoNoCurrent