Tylenol Extra Strength

Product NDC: 73097-012
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 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-012-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-012-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73097-012-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-012-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-012-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73097-012-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-012-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-012-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73097-012-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-012-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-012-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73097-012-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-012-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-012-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73097-012-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-012-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-012-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73097-012-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-012-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-012-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73097-012-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-012-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-012-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73097-012-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-012-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-012-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73097-012-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-012-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-012-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73097-012-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-012-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-012-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73097-012-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-012-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-012-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73097-012-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-012-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-012-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73097-012-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-012-50	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-012-40	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73097-012-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-012-50	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-012-40	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73097-012-02	`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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ed90757-833e-f4d9-e053-2995a90a29db	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73097-012-02	2023-01-30	C162847	48780-1	f386c649-c8c6-0266-e053-dadaa90a7c1a	Tylenol Extra Strength
73097-012-40	2023-01-30	C162847	48780-1	f386c649-c8c6-0266-e053-dadaa90a7c1a	Tylenol Extra Strength
73097-012-50	2023-01-30	C162847	48780-1	f386c649-c8c6-0266-e053-dadaa90a7c1a	Tylenol Extra Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 30 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bayer Rapid Relief	ASPIRIN/CAFFEINE ORAL POWDER	Bayer HealthCare LLC.	f1fecbb0-5b55-fe8f-e053-2995a90a0977	2025-12-05	Warnings	Exact identifier application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-Eleven	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45381b1c-2acd-1524-e063-6394a90a83d9	2025-12-05	Warnings	Exact identifier application number: M013
Acetaminophen Easy Tabs Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	729132cd-f209-447a-8949-a90b5a5c01da	2025-12-05	Warnings	Exact identifier application number: M013
Menstrual Pain Relief Complete	ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE	Shield Pharmaceuticals Corp	05fda811-d65f-41b2-89e4-297cdddb3d99	2025-12-05	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Health Pharma USA, LLC	3165b0a3-556b-6abe-e063-6394a90a7682	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Bayer HealthCare LLC.	44a08904-68b9-4d06-a28d-21aae3d6140c	2025-12-04	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7a29dde6-a177-6206-e053-2991aa0a01f2	2025-12-04	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	Geri-Care Pharmaceutical Corp	7570aaa2-3238-4cd3-b788-915caa970dba	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Headache	ASPIRIN AND CAFFEINE	Bayer HealthCare LLC.	c0a92873-0914-6a86-e053-2995a90ac41c	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	ALKA-SELTZER ORIGINAL FLAVOR	Bayer HealthCare LLC.	07478020-5ba0-3b67-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	0dba1329-5b0d-5688-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	78537dcf-b157-4b67-a8b2-5cb144815166	2025-12-04	Warnings	Exact identifier application number: M013
BAYER Aspirin Extra Strength Caplets	BAYER ASPIRIN EXTRA STRENGTH	Bayer HealthCare LLC.	0ae64cdb-4ea0-23af-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored	ASPIRIN	Bayer HealthCare LLC.	070d5713-e018-2913-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Low Dose	ASPIRIN	Bayer HealthCare LLC.	075b103e-0bb4-4b7a-ac0e-5645bcbd0a07	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Aspirin Regimen enteric coated	ASPIRIN	Bayer HealthCare LLC.	0c6ae05f-7634-34d1-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
aspirin pain relief	ASPIRIN	Rite Aid Corporation	ae9d9977-7576-4894-8a32-454828abec9a	2025-12-04	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	RMT HEALTH LLC	2bacffd1-4870-73af-e063-6294a90a19c8	2025-12-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rite Aid Corporation	d9caee45-be43-45ec-927f-e7fec5c14f07	2025-12-02	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	8ed90757-833e-f4d9-e053-2995a90a29db	3
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	8ed90757-833e-f4d9-e053-2995a90a29db	3
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	8ed90757-833e-f4d9-e053-2995a90a29db	3
198440	acetaminophen 500 MG Oral Tablet	SCD	8ed90757-833e-f4d9-e053-2995a90a29db	3
198440	APAP 500 MG Oral Tablet	SY	8ed90757-833e-f4d9-e053-2995a90a29db	3
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	8ed90757-833e-f4d9-e053-2995a90a29db	3
209459	Tylenol 500 MG Oral Tablet	SY	8ed90757-833e-f4d9-e053-2995a90a29db	3
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	8ed90757-833e-f4d9-e053-2995a90a29db	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73097-012-02	73097001202	1 POUCH in 1 CARTON (73097-012-02) / 2 TABLET, FILM COATED in 1 POUCH	1 pouch	2019-07-22	0000-00-00	No	No	Current
73097-012-40	73097001240	20 POUCH in 1 CARTON (73097-012-40) / 2 TABLET, FILM COATED in 1 POUCH	20 pouch	2019-07-22	0000-00-00	No	No	Current
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