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 48 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN Asclemed USA, Inc. 878dab20-668b-4d7a-a5f8-794a587564d5 2025-02-13 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN CVS HEALTH CORP bbc48c9e-7eb8-2c67-e053-2a95a90a8552 2025-02-13 Warnings Exact identifier application number: M013 Dye Free Infants Pain and Fever ACETAMINOPHEN CVS 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 2025-02-13 Warnings Exact identifier application number: M013 NOTTS - Extra Strength 500 mg ACETAMINOPHEN VIVUNT PHARMA LLC e677f43d-b4ce-e5b0-e053-2a95a90ad67e 2025-02-12 Warnings Exact identifier application number: M013 Acetaminophen, Aspirin, Caffeine ACETAMINOPHEN, ASPIRIN, CAFFEINE LEADER/ Cardinal Health 110, Inc. b3773f02-02a9-33c8-e053-2995a90a2235 2025-02-11 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABORATORIES, INC. c9f80d24-bd05-e1ce-e053-2995a90aa646 2025-02-10 Warnings Exact identifier application number: M013 Low dose Aspirin ASPIRIN 81 MG DELAYED RELEASE TABLETS WALGREENS c25c55aa-9932-0a55-e053-2a95a90a3d1e 2025-02-10 Warnings Exact identifier application number: M013 AeroTab Pain Reliever PAIN RELIEVER Aero Healthcare 40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f 2025-02-10 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Time-Cap Labs, Inc 5fbd8bb3-46f9-4089-9a21-b6af97a06106 2025-02-08 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN TIME CAP LABS INC c193dbc0-cc80-4a7c-aa29-457a20edf835 2025-02-08 Warnings Exact identifier application number: M013 Daytime Severe Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HBR Genexa Inc. 22f23aeb-f874-6e54-e063-6394a90a9565 2025-02-07 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN BETTER LIVING BRANDS LLC. f3008928-c555-64ad-e053-2995a90a7307 2025-02-05 Warnings Exact identifier application number: M013 Aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300dfbc-7137-79d1-e053-2995a90a636e 2025-02-05 Warnings Exact identifier application number: M013 Low dose aspirin 81mg ASPIRIN BETTER LIVING BRANDS LLC. f300c30b-ab1a-a1b4-e053-2a95a90a1294 2025-02-05 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL Strategic Sourcing Services LLC 5d174187-cf89-41ff-9a64-10e0276daf17 2025-02-05 Warnings Exact identifier application number: M013 good sense pain relief ACETAMINOPHEN Bryant Ranch Prepack c226205d-7c3c-49af-b3e2-fc7b09ad7857 2025-02-05 Warnings Exact identifier application number: M013 Dye Free Childrens Acetaminophen ACETAMINOPHEN PAI Holdings, LLC dba PAI Pharma a69fca9d-c0a0-4321-bf03-5c8e99cc07cc 2025-02-04 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN-CAFFEINE TARGET CORPORATION 8ed1679d-d3a1-11b1-e053-2995a90a61ad 2025-01-31 Warnings Exact identifier application number: M013 ValuMeds Extra Strength Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Cabinet Health P.B.C. 0f864e73-e4b8-4e23-8990-8439ac17bd58 2025-01-31 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN TABLETS 500 MG WALGREENS c25bfe92-0196-0489-e053-2995a90abea1 2025-01-30 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