TYLENOL Extra Strength

Product NDC: 50580-209
11-digit product format: 505800209
Labeler code: 50580
Product ID: 50580-209_3efe12ef-7f94-9548-e063-6294a90aba91
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: POWDER
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-15
Substance: ACETAMINOPHEN
Active strength: 500 mg/.95g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/.95g

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
2374360	Internal RxNorm lookup
2374361	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
ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-209-02	TYLENOL Extra Strength	12 in 1 CARTON	POWDER	12	7
50580-209-02	TYLENOL Extra Strength	0.95 g in 1 PACKET	POWDER	0.95	7
50580-209-04	TYLENOL Extra Strength	32 in 1 CARTON	POWDER	32	7
50580-209-04	TYLENOL Extra Strength	0.95 g in 1 PACKET	POWDER	0.95	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-209-02	EA - Each	50580-209	efe66416-47ae-407a-92a8-7561b45e7a31	1	2022-07-06
50580-209-04	EA - Each	50580-209	2a4b1688-45e3-456c-90cf-9e36a2d011c2	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-209	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) POWDER [KENVUE BRANDS LLC]	6	Current NDC, Legacy NDC, 4 package rows	20241103_ab02080a-c903-4e4a-a9f3-2b8197ed2f2b.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 67 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	cfaf9495-e654-4dfc-ba23-d2358c3720c4	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	18ff2df8-ee65-4219-ad93-cf5090bfac2d	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	9fdbaf5e-f88b-4d18-97df-0b2e8dddf377	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low dose	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	bfb9af64-3195-44bf-bcf3-6b36b40d3cc7	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	1ac7ed71-5afe-d09c-e063-6294a90a3b88	2024-06-13	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	3ce5bbf2-d449-464e-abeb-5c26866d1ab5	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	2024-06-13	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	3f73a359-59d7-47bb-872e-914b0db719af	2024-06-13	Warnings	Exact identifier application number: M013
topcare infants pain and fever	ACETAMINOPHEN	Topco Associates LLC	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	2024-06-13	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Trifecta Pharmaceuticals USA LLC	026bf664-d598-73de-e063-6394a90a9206	2024-06-12	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	7c73fc75-af9b-177c-e053-2a91aa0ada56	2024-06-12	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Topco Associates	4a6a1dbb-c813-42fd-9bb8-497aec339466	2024-06-11	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	fa234639-caf8-4c52-9ffe-f1c0c057ee5b	2024-06-10	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	bc18590d-6481-4efe-8a3b-974f7543b754	2024-06-10	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	H-E-B	085b35db-62e4-38db-e063-6394a90a9763	2024-06-07	Warnings	Exact identifier application number: M013
pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	The Kroger Co.	5691ac45-5732-412e-abb8-2bfaac59160e	2024-06-07	Warnings	Exact identifier application number: M013
Cafiaspirina Rapid Headache Relief	ASPIRIN, CAFFEINE	Belmora LLC	d890acec-6528-4fb7-8d59-6c572a3f0786	2024-06-07	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	TARGET Corporation	611bc1ce-460a-44a3-8e2d-b28a399d9a44	2024-06-06	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Meijer Distribution Inc	033a6153-2651-4703-8a94-def461838113	2024-06-05	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
2374360	acetaminophen 500 MG Oral Powder	PSN	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374361	Tylenol DISSOLVE PACKS 500 MG Oral Powder	PSN	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374361	acetaminophen 500 MG Oral Powder [Tylenol]	SBD	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374360	acetaminophen 500 MG Oral Powder	SCD	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374360	APAP 500 MG Oral Powder	SY	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374361	APAP 500 MG Oral Powder [Tylenol]	SY	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7
2374361	Tylenol 500 MG Oral Powder	SY	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-209-02	50580020902	12 PACKET in 1 CARTON (50580-209-02) / .95 g in 1 PACKET	12 packet	2020-06-15	0000-00-00	No	No	Current
50580-209-04	50580020904	32 PACKET in 1 CARTON (50580-209-04) / .95 g in 1 PACKET	32 packet	2020-06-15	0000-00-00	No	No	Current