percogesic extra strength

Generic: acetaminophen and diphenhydramine

Labeler: medtech products inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name percogesic extra strength
Generic Name acetaminophen and diphenhydramine
Labeler medtech products inc.
Dosage Form CAPSULE, COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine 12.5 mg/1

Manufacturer
Medtech Products Inc.

Identifiers & Regulatory

Product NDC 63029-054
Product ID 63029-054_dd068345-eb74-40b1-80b5-ef9df6fde1cd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2010-07-07

Pharmacologic Class

Established (EPC)
histamine-1 receptor antagonist [epc]
Mechanism of Action
histamine h1 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63029054
Hyphenated Format 63029-054

Supplemental Identifiers

UNII
362O9ITL9D 8GTS82S83M
NUI
N0000000190 N0000175587

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name percogesic extra strength (source: ndc)
Generic Name acetaminophen and diphenhydramine (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 12.5 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-40) / 40 CAPSULE, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-60) / 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

63029-054-40 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-40) / 40 CAPSULE, COATED in 1 BOTTLE, PLASTIC 63029-054-60 1 BOTTLE, PLASTIC in 1 CARTON (63029-054-60) / 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine (12.5 mg/1)

Linked Drug Pages (1)

Percogesic Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dd068345-eb74-40b1-80b5-ef9df6fde1cd", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["362O9ITL9D", "8GTS82S83M"], "spl_set_id": ["2c5f1140-fb83-42c9-b0b1-5e2bd69340bb"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["Medtech Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63029-054-40)  / 40 CAPSULE, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63029-054-40", "marketing_start_date": "20100707"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63029-054-60)  / 60 CAPSULE, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "63029-054-60", "marketing_start_date": "20100707"}], "brand_name": "Percogesic Extra Strength", "product_id": "63029-054_dd068345-eb74-40b1-80b5-ef9df6fde1cd", "dosage_form": "CAPSULE, COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "63029-054", "generic_name": "acetaminophen and diphenhydramine", "labeler_name": "Medtech Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Percogesic", "brand_name_suffix": "Extra Strength", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE", "strength": "12.5 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100707", "listing_expiration_date": "20261231"}