Extra Strength No-Pain

Product NDC: 71309-001
11-digit product format: 713090001
Labeler code: 71309
Product ID: 71309-001_3371e8dc-ae55-9a65-e063-6394a90aeaac
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET
Route: ORAL
Labeler: Safrel Pharmaceuticals, LLC.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-07-31
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 · 39 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
2025-04-01 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	71309-001-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71309-001-05	`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	71309-001-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71309-001-05	`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	71309-001-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71309-001-05	`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	71309-001-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71309-001-05	`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	71309-001-40	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71309-001-05	`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	71309-001-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71309-001-05	`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	71309-001-40	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71309-001-05	`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	71309-001-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71309-001-05	`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	71309-001-40	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71309-001-05	`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	71309-001-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71309-001-05	`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	71309-001-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71309-001-05	`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	71309-001-40	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71309-001-05	`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	71309-001-40	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71309-001-05	`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: Extra Strength No-Pain
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
873f01dd-0701-5fd3-e053-2a95a90a6463	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71309-001-05	2025-04-23	Acetaminophen Extra Strength 500 mg
71309-001-40	2025-04-23	Acetaminophen Extra Strength 500 mg
71309-001-05	2023-07-28	Acetaminophen Extra Strength 500 mg
71309-001-40	2023-07-28	Acetaminophen Extra Strength 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71309-001-05	Extra Strength No-Pain	500 in 1 BOTTLE	TABLET	500	6
71309-001-40	Extra Strength No-Pain	40 in 1 BOTTLE	TABLET	40	6
71309-001-40	Extra Strength No-Pain	1 in 1 CARTON	TABLET	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71309-001	EXTRA STRENGTH NO-PAIN (ACETAMINOPHEN) TABLET [SAFREL PHARMACEUTICALS, LLC.]	6	Current NDC, Legacy NDC, 3 package rows	20250425_873f01dd-0701-5fd3-e053-2a95a90a6463.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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD REMEDIES Extra Strength Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d642d8e-c154-a970-e063-6294a90a03bf	2025-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4	2025-03-07	Warnings	Exact identifier application number: M013
Redicare Non-Aspirin 500mg	REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG	Redicare LLC	2f229898-1777-732c-e063-6394a90a76bc	2025-03-04	Warnings, Adverse reactions	Exact identifier application number: M013
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	77429b7f-78e4-42c0-8679-ae8da1748848	2025-02-26	Warnings	Exact identifier application number: M013
AeroTab Non-Aspirin	ACETAMINOPHEN 500MG ES	Aero Healthcare	faa3a4ef-3c70-06ca-e053-6394a90a512d	2025-02-26	Warnings	Exact identifier application number: M013
Bufferin Regular Strength Pain Relief	ASPIRIN	Genomma Lab USA	3543b2bf-1062-468a-a5dc-eabb2408af8c	2025-02-25	Warnings	Exact identifier application number: M013
Calmour Childrens Acetaminophen Strips Chewable	ACETAMINOPHEN ORAL CHEWABLE 80 MG	Calmour	ae47b027-4f29-45bb-a8bd-812978932835	2025-02-22	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	f9de7c2f-016b-4f40-8b5e-141ad194be97	2025-02-20	Warnings	Exact identifier application number: M013
Genexa Acetaminophen PM Extra Strength	ACETAMINOPHEN	Genexa Inc.	d82cf6f3-a291-ca2b-e053-2a95a90a6de1	2025-02-20	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Advagen Pharma Limited	8b9456c9-a56b-4748-adb8-c66d6bf072e8	2025-02-19	Warnings	Exact identifier application number: M013
Genexa Childrens Acetaminophen	ACETAMINOPHEN	Genexa Inc.	d89fd9d8-d88e-3968-e053-2a95a90afc5f	2025-02-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	debfa787-7a48-48b5-94b0-612820524032	2025-02-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	b16e5dcf-b290-4ff2-a150-4b875647ec9a	2025-02-19	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	2025-02-18	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	c830320e-72ba-48ff-a4cd-250ac5650bf0	2025-02-18	Warnings	Exact identifier application number: M013
Aspirina Caplets	ASPIRIN	Bayer HealthCare LLC.	2e6f5ba8-8e8b-6059-e063-6394a90adcd5	2025-02-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	da7d95af-6583-429d-8d04-e0424f32e9ad	2025-02-17	Warnings	Exact identifier application number: M013
GOODYS Mental Alert	ASPIRIN AND CAFFEINE	Medtech Products Inc.	31ef6d07-d314-4d09-abcd-389ba66cbcc5	2025-02-17	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	873f01dd-0701-5fd3-e053-2a95a90a6463	6
198440	acetaminophen 500 MG Oral Tablet	SCD	873f01dd-0701-5fd3-e053-2a95a90a6463	6
198440	APAP 500 MG Oral Tablet	SY	873f01dd-0701-5fd3-e053-2a95a90a6463	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71309-001-05	71309000105	500 TABLET in 1 BOTTLE (71309-001-05)	500 tablet	2017-07-31	0000-00-00	No	No	Current
71309-001-40	71309000140	1 BOTTLE in 1 CARTON (71309-001-40) / 40 TABLET in 1 BOTTLE	1 bottle	2017-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Extra Strength 500 mg	Safrel Pharmaceuticals, LLC.	2025-04-23	HUMAN OTC DRUG LABEL	6