Home NDC 63868-987 Pain Relief
Product NDC 63868-987
11-digit product format 638680987
Labeler code 63868
Product ID 63868-987_827f97ea-efba-4fe6-a603-aaea8cdcd902
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-05-10
Marketing end 2028-04-30
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
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, Non-Aspirin 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-987-10 Pain ReliefExtra Strength, Non-Aspirin 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 20 63868-987-10 Pain ReliefExtra Strength, Non-Aspirin 1 in 1 CARTON TABLET, COATED 1 20 63868-987-50 Pain ReliefExtra Strength, Non-Aspirin 1 in 1 CARTON TABLET, COATED 1 20 63868-987-50 Pain ReliefExtra Strength, Non-Aspirin 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 POVIDONES INACTIVE INGREDIENT FZ989GH94E EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXTRA STRENGTH NON-ASPIRIN (ACETAMINOPHEN) CAPSULE, GELATIN COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-987 PAIN RELIEF EXTRA STRENGTH, NON-ASPIRIN (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC] 18 Current NDC, Legacy NDC, 4 package rows 20240608_1fb5e871-45fd-46fe-bf73-5192f8316e8e.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 13 of 79 · 1,579 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 63868-987-10 63868098710 1 BOTTLE, PLASTIC in 1 CARTON (63868-987-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 2028-04-30 No No Current 63868-987-50 63868098750 1 BOTTLE, PLASTIC in 1 CARTON (63868-987-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 2028-04-30 No No Current