Percogesic Extra Strength

Product NDC
63029-049
Requested package NDC
63029-049-13
11-digit product format
630290049
Labeler code
63029
Product ID
63029-049_97122b17-0ff8-4fcd-b5ea-8f6becc692bd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
Medtech Products Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-07-07
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE
Active strength
500 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 packagepackage63029-04963029-049-13DDiscontinued 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 · 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 EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
DIPHENHYDRAMINEACTIVE INGREDIENT8GTS82S83MPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPERCOGESIC EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-049-13630290049131 BOTTLE, PLASTIC in 1 BOX (63029-049-13) > 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC2010-07-070000-00-00NoNoCurrent