Home NDC 73097-012-50 Tylenol Extra Strength
Product NDC 73097-012
Requested package NDC 73097-012-50
11-digit product format 730970012
Labeler code 73097
Product ID 73097-012_518f6c13-a0c6-5f9c-e063-6294a90a74d5
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Savings Distributors LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-22
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 Tylenol Extra Strength
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73097-012-02 Tylenol Extra Strength 1 in 1 CARTON TABLET, FILM COATED 1 3 73097-012-02 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 3 73097-012-40 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 3 73097-012-40 Tylenol Extra Strength 20 in 1 CARTON TABLET, FILM COATED 20 3 73097-012-50 Tylenol Extra Strength 25 in 1 BOX TABLET, FILM COATED 25 3 73097-012-50 Tylenol Extra Strength 2 in 1 POUCH TABLET, FILM COATED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73097-012 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SAVINGS DISTRIBUTORS LLC] 1 Current NDC, Legacy NDC, 6 package rows 20190730_8ed90757-833e-f4d9-e053-2995a90a29db.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 44 of 79 · 1,570 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirina Cafeina ASPIRIN,CAFFEINE Bayer HealthCare LLC. 2e709acc-325a-baca-e063-6394a90a24be 2025-06-12 Warnings Exact identifier application number: M013 Aspirin ASPIRIN CHAIN DRUG MARKETING ASSOCIATION, INC. 696f55b1-536c-40c4-91f7-b572c39220db 2025-06-11 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc. 6dea9e11-ff99-63c7-e053-2a91aa0a5b54 2025-06-10 Warnings Exact identifier application number: M013 Children Acetaminophen Oral Solution ACETAMINOPHEN MAJOR PHARMACEUTICALS cfca5147-f390-40bd-8f13-c5b3b8d1c5b0 2025-06-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Trifecta Pharmaceuticals USA LLC 372be427-acbd-c10c-e063-6294a90a572d 2025-06-09 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS Pharmacy d6c8118c-bf78-4194-9b14-8de33c3ecdb7 2025-06-06 Warnings Exact identifier application number: M013 Dolo-NeuroBion ACETAMINOPHEN BENARD INDUSTRIES INC b8310770-84d1-4a6f-8e23-9974947f92f1 2025-06-04 Warnings Exact identifier application number: M013 Menstrual Complete Maximum Strength ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE Rite Aid Corporation 69bda7d7-8660-4e8d-b8ac-892a3b1f2124 2025-06-03 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN KinderFarms, LLC fb74e8f9-d72f-4681-90bd-df48364405b5 2025-06-01 Warnings Exact identifier application number: M013 Pain and Fever Childrens ACETAMINOPHEN P & L Development, LLC b815fcae-8bba-4737-ac10-29a32fb69275 2025-05-30 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN KinderFarms, LLC 81cc4900-226b-4c49-ba9c-5747d2a501b1 2025-05-29 Warnings Exact identifier application number: M013 good sense pain relief pm extra strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Bryant Ranch Prepack e08a7ab1-4b68-422a-97bd-2c5326633943 2025-05-29 Warnings Exact identifier application number: M013 Acetaminophen Gelcaps ACETAMINOPHEN Kroger 30d3f2d0-da35-7f6f-e063-6294a90a9c22 2025-05-23 Warnings Exact identifier application number: M013 Kids Pain and Fever ACETAMINOPHEN Genexa Inc. fcffa7e6-145c-6bc0-e053-6294a90a4751 2025-05-23 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN CHAIN DRUG MARKETING ASSOCIATION, INC. 1c083e29-8732-4ecd-ab4b-9038acbd0b9d 2025-05-22 Warnings Exact identifier application number: M013 TYLENOL For Children Plus Adults ACETAMINOPHEN Kenvue Brands LLC 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42 2025-05-21 Warnings Exact identifier application number: M013 Children Acetaminophen ACETAMINOPHEN AARNA USA INC. 25bcb9d5-f388-4ae7-8037-970ffe8d17f0 2025-05-16 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 35478de8-50d0-5d0a-e063-6294a90a88ba 2025-05-16 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Preferred Pharmaceuticals Inc. 95f4b628-6d35-4f6b-91f9-b2d117f8e821 2025-05-16 Warnings Exact identifier application number: M013 good neighbor pharmacy childrens pain and fever ACETAMINOPHEN Amerisource Bergen 268a789b-8f31-4739-9777-523249cac326 2025-05-13 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 73097-012-50 73097001250 25 POUCH in 1 BOX (73097-012-50) / 2 TABLET, FILM COATED in 1 POUCH 25 pouch 2019-07-22 0000-00-00 No No Current