Home NDC 50844-519 Pain Reliever
Product NDC 50844-519
11-digit product format 508440519
Labeler code 50844
Product ID 50844-519_9f5e3344-4f7b-4096-a4f0-929e140c175c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-05-10
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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Reliever
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 50844-519-02 Pain RelieverExtra Strength 12 in 1 BOTTLE, PLASTIC TABLET, COATED 12 17 50844-519-02 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-12 Pain RelieverExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 17 50844-519-15 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-15 Pain RelieverExtra Strength 50 in 1 BOTTLE TABLET, COATED 50 17 50844-519-20 Pain RelieverExtra Strength 225 in 1 BOTTLE, PLASTIC TABLET, COATED 225 17 50844-519-21 Pain RelieverExtra Strength 1 in 1 CARTON TABLET, COATED 1 17 50844-519-21 Pain RelieverExtra Strength 16 in 1 BOTTLE, PLASTIC TABLET, COATED 16 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET [L.N.K. INTERNATIONAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-519 PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [L.N.K. INTERNATIONAL, INC.] 16 Current NDC, Legacy NDC, 8 package rows 20241109_72babe91-2586-4f05-ae90-6debfd23aa5d.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 38 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC ab02080a-c903-4e4a-a9f3-2b8197ed2f2b 2025-09-17 Warnings Exact identifier application number: M013 Childrens TYLENOL ACETAMINOPHEN Kenvue Brands LLC 79669930-f744-4bb1-8325-b75951489b64 2025-09-17 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL L.N.K. International, Inc. ff199db8-c7ea-4b6e-ad8b-3ceeca883d92 2025-09-15 Warnings Exact identifier application number: M013 Acetaminophen PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL FOODHOLD U.S.A., LLC fdd7ce80-d6be-41b9-affd-d024cf306b50 2025-09-12 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever ACETAMINOPHEN INGLES MARKETS, INC. 3e89240b-0e27-fde4-e063-6394a90a779f 2025-09-11 Warnings Exact identifier application number: M013 Aspirin 81 mg Low Dose ASPIRIN HEB 926fe7b6-9607-469f-912f-4019891067a9 2025-09-10 Warnings Exact identifier application number: M013 Bayer Genuine Aspirin ASPIRIN Unifirst First Aid Corporation 356e4ff4-a7f1-4a50-9b86-2555e232b300 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Aspirin ASPIRIN Unifirst First Aid Corporation b5a469c1-9ab4-5bd7-e053-2995a90a86d1 2025-09-09 Warnings Exact identifier application number: M013 Medique Products Aspirin ASPIRIN Unifirst First Aid Corporation 9b28fed0-a993-ca72-e053-2995a90ac7fd 2025-09-09 Warnings Exact identifier application number: M013 Unishield Aspirin ASPIRIN Unishield ba106b20-32ac-df90-e053-2995a90adaef 2025-09-09 Warnings Exact identifier application number: M013 Medi First Pain Ache ASPIRIN,CAFFEINE Unifirst First Aid Corporation e82d02d5-3e44-a8f8-e053-2a95a90a2688 2025-09-09 Warnings Exact identifier application number: M013 Medique at Home Back Pain Relief MAGNESIUM SALICYLATE Unifirst First Aid Corporation e56c4aef-fa0b-74db-e053-2a95a90a9745 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Aspirin ASPIRIN Bellegrove Medical Supply, Inc. bae80044-ad7f-3bf5-e053-2995a90a42f9 2025-09-09 Warnings Exact identifier application number: M013 McKesson Aspirin ASPIRIN McKesson Medical-Surgical dabd741e-e11c-52c1-e053-2a95a90a91d5 2025-09-09 Warnings Exact identifier application number: M013 Travel Savvy Non-Aspirin ACETAMINOPHEN 325MG Bellegrove Medical Supply, Inc. 6ab08633-5d5a-42b2-e053-2991aa0ab41a 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC 1c7369ea-46b6-407c-aa4b-048eb72ff03f 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Extra Strength Aspirin Free ACETAMINOPHEN Conney Safety Products, LLC a524c36a-38f3-4266-8f45-589e19400328 2025-09-09 Warnings Exact identifier application number: M013 Direct Safety Aspirin ASPIRIN Direct Safety ba9ba697-d3df-49d7-e053-2a95a90af406 2025-09-09 Warnings Exact identifier application number: M013 McKesson Acetaminophen 325 ACETAMINOPHEN McKesson Medical-Surgical, Inc. bc2daba5-ce8b-bbda-e053-2a95a90a6f33 2025-09-09 Warnings Exact identifier application number: M013 Uline Acetaminophen Extra Strength ACETAMINOPHEN Uline 90167594-0a49-2492-e053-2a95a90a1401 2025-09-09 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50844-519-02 50844051902 1 BOTTLE, PLASTIC in 1 CARTON (50844-519-02) > 12 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current 50844-519-12 50844051912 100 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-12) 2023-11-14 No No Current 50844-519-15 50844051915 1 BOTTLE in 1 CARTON (50844-519-15) > 50 TABLET in 1 BOTTLE 1 bottle 2004-05-10 0000-00-00 No No Current 50844-519-20 50844051920 225 TABLET, COATED in 1 BOTTLE, PLASTIC (50844-519-20) 2023-11-14 No No Current 50844-519-21 50844051921 1 BOTTLE, PLASTIC in 1 CARTON (50844-519-21) / 16 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current