Home NDC 63868-084 Pain Relief
Product NDC 63868-084
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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 71 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dye Free Infants Pain and Fever ACETAMINOPHEN WALGREENS 0b1d88d8-56ff-9e9d-e063-6394a90a015c 2024-04-09 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE H E B 4d572228-3141-4539-9c3d-2fd06e94eee3 2024-04-09 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 1b5ff867-5442-4cf8-bd1e-530093cc88f8 2024-04-05 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 0faa3592-4d56-4645-9a0e-066e0bdfebb6 2024-04-05 Warnings Exact identifier application number: M013 Pain Relief Childrens Dye Free ACETAMINOPHEN H E B 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 2024-04-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN H E B edb321dd-e5cb-4031-a8a8-efce9e86fe16 2024-04-03 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN H E B a0c0277e-50aa-4328-8f93-ab20c6176b2b 2024-04-03 Warnings Exact identifier application number: M013 Regular Strength Enteric coated aspirin ASPIRIN Bryant Ranch Prepack bda805ab-7f37-405d-a144-4e06ad9a29a1 2024-04-03 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Family Dollar (FAMILY WELLNESS) 650cb15e-c448-4df3-b0f8-4398be05d841 2024-03-27 Warnings Exact identifier application number: M013 Good Sense Effervescent Pain Relief ASPIRIN Perrigo Direct, Inc. 103027a7-2f0e-8d8c-e063-6294a90aedc7 2024-03-26 Warnings Exact identifier application number: M013 rugby infants acetaminophen ACETAMINOPHEN Rugby Laboratories 8aa9ac68-ca61-4163-a876-52034138c1ea 2024-03-25 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 08a18481-f029-f01f-e063-6294a90aac65 2024-03-21 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 0d106fa2-2a77-deb2-e063-6394a90a2dac 2024-03-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 872c5220-a379-4dc1-b99c-f11ebb82db35 2024-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 79886972-47a4-44c5-a131-1a691a328103 2024-03-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 5ffcc78d-9163-4cb4-8811-ae9f0142806a 2024-03-18 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER HF Acquisition Co LLC, DBA HealthFirst 13e621dc-b2b4-98fd-e063-6394a90acc75 2024-03-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS PHARMACY, INC 097a9c98-a092-400d-9600-6797b0b9a50c 2024-03-15 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets and Excedrin Tension Headache ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC 978a9d27-6d41-42cb-a193-11314923d2ac 2024-03-14 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC b3812d27-40af-40d7-864a-dfa4ae34cb9e 2024-03-14 Warnings Exact identifier application number: M013
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 63868-084-05 63868008405 500 TABLET, COATED in 1 BOTTLE, PLASTIC (63868-084-05) 2014-06-13 0000-00-00 No No Current 63868-084-10 63868008410 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-10) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-06-13 0000-00-00 No No Current 63868-084-20 63868008420 100 in 1 BOTTLE, PLASTIC Historical 63868-084-24 63868008424 1 BOTTLE, PLASTIC in 1 CARTON (63868-084-24) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2014-06-13 0000-00-00 No No Current 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