Adwe Feverx Acetaminophen Caplets, 500 mg

Product NDC: 71009-109
11-digit product format: 710090109
Labeler code: 71009
Product ID: 71009-109_31a5e50a-d3b9-f512-e063-6394a90a8c10
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: Aurex Laboratories Limited Liability Company
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-09
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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71009-109-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71009-109-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71009-109-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71009-109-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71009-109-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71009-109-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71009-109-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71009-109-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71009-109-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71009-109-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71009-109-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71009-109-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71009-109-01	I	Inactivated by FDA	`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: Adwe Feverx Acetaminophen Caplets, 500 mg
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
948c5826-6f35-484d-bb3f-cecf6a4b5c13	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71009-109-01	2024-12-23	C162847	48780-1	f386c649-c0c3-0266-e053-dadaa90a7c1a	Adwe Feverx Acetaminophen Caplets, 500 mg
71009-109-01	2023-01-30	C162847	48780-1	f386c649-c0c3-0266-e053-dadaa90a7c1a	Adwe Feverx Acetaminophen Caplets, 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71009-109-01	Adwe Feverx Acetaminophen Caplets, 500 mgExtra Strength	100 in 1 BOTTLE	TABLET	100		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71009-109	ADWE FEVERX ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH (ACETAMINOPHEN) TABLET [AUREX LABORATORIES LIMITED LIABILITY COMPANY]	6	Current NDC, Legacy NDC, 1 package rows	20250402_948c5826-6f35-484d-bb3f-cecf6a4b5c13.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 60 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen Regular Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	1462b308-a6a5-49ca-ab29-cacbf62caf0b	2024-10-17	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f3db8598-fe0e-4c53-a023-5f5f8f002cc6	2024-10-17	Warnings	Exact identifier application number: M013
acetaminophen pm extra strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	f86a11af-6d3c-4638-870d-a663ddf49371	2024-10-17	Warnings	Exact identifier application number: M013
Acetaminophen Gelcaps Extra Strength	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	3588a3ef-a493-43ed-96e0-c259f0d087db	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	a2186895-944b-48cb-b3c2-eac208866c34	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Regular Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	6a5d43c8-f4b7-4447-b2e1-53eb12208ef0	2024-10-17	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin	ASPIRIN	STRATEGIC SOURCING SERVICES LLC	32cc6e05-84c1-4710-bebc-cb6e7133dc54	2024-10-17	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	STRATEGIC SOURCING SERVICES LLC	2ca87a29-1f54-4da4-a66f-3b3dd4f0396c	2024-10-17	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	STRATEGIC SOURCING SERVICES LLC	9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e	2024-10-17	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Kroger Company	453f62d5-f580-4d19-bfae-4f78c2a6b6d6	2024-10-16	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	FSA Store Inc.	ec6add55-f4a3-7818-e053-2a95a90aee04	2024-10-16	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	FSA Store Inc.	062e7b7b-d052-82b0-e063-6294a90a7cce	2024-10-16	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	FSA STORE INC.	f4322f34-ac19-371e-e053-2a95a90ac864	2024-10-16	Warnings	Exact identifier application number: M013
Low dose Chewable Aspirin	ASPIRIN	FSA STORE INC.	f939b44c-93b6-ca61-e053-6394a90ae586	2024-10-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	850b5ad8-8774-413c-ae38-022215a94f95	2024-10-16	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	DISCOUNT DRUG MART	af0f50d2-3e2d-f723-e053-2995a90a0d4b	2024-10-16	Warnings	Exact identifier application number: M013
Enteric Coated Aspirin	ASPIRIN	DISCOUNT DRUG MART	03ed19dd-1cfc-47d5-b83e-ffa2ebe93f48	2024-10-16	Warnings	Exact identifier application number: M013
PAIN RELIEF Regular Strength	ACETAMINOPHEN	AMERICAN SALES COMPANY	2e3eabc8-193b-4397-a43c-db838eb16e67	2024-10-15	Warnings	Exact identifier application number: M013
Chewable Aspirin	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d68ea-7f25-881f-e053-2995a90aa47f	2024-10-15	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d750e-5a85-77f5-e053-2995a90a6915	2024-10-15	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	948c5826-6f35-484d-bb3f-cecf6a4b5c13	6
198440	acetaminophen 500 MG Oral Tablet	SCD	948c5826-6f35-484d-bb3f-cecf6a4b5c13	6
198440	APAP 500 MG Oral Tablet	SY	948c5826-6f35-484d-bb3f-cecf6a4b5c13	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71009-109-01	71009010901	100 TABLET in 1 BOTTLE (71009-109-01)	100 tablet	2021-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Adwe Feverx Acetaminophen Caplets, 500 mg	Aurex Laboratories Limited Liability Company \| Adwe Products & Imports Inc.	2025-03-31	HUMAN OTC DRUG LABEL	6