Home NDC 63868-084-50 Pain Relief
Product NDC 63868-084
Requested package NDC 63868-084-50
11-digit product format 638680084
Labeler code 63868
Product ID 63868-084_243531d9-3c42-d20a-e063-6294a90a2b09
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Chain Drug Marketing Association
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-06-13
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pain Relief
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-084-05 Pain ReliefExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 5 63868-084-10 Pain ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5 63868-084-10 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 63868-084-20 Pain ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 5 63868-084-20 Pain ReliefExtra Strength 2 in 1 CARTON TABLET, COATED 2 5 63868-084-24 Pain ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 5 63868-084-24 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 63868-084-50 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 5 63868-084-50 Pain ReliefExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-084 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION] 5 Current NDC, Legacy NDC, 9 package rows 20241013_68a52858-35c5-402a-8ceb-8d8a7c1e5f6c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63868-084-50 63868008450 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-50) > 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-06-13 0000-00-00 No No Current