Genexa Acetaminophen

Product NDC: 69676-0059
11-digit product format: 696760059
Labeler code: 69676
Product ID: 69676-0059_51590662-8dac-1b90-e063-6294a90a49a2
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Genexa Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-17
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 · 9 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
2025-02-02 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	69676-0059-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69676-0059-2	`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	69676-0059-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69676-0059-2	`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	69676-0059-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69676-0059-2	`0efc9e666f02…`	`f202fb6c5f17…`

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: Genexa Acetaminophen
Brand name suffix: 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 · 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
d6f968ca-719f-5a68-e053-2995a90a4afa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69676-0059-2	2025-02-26	Acetaminophen Extra Strength Caplets
69676-0059-5	2025-02-26	Acetaminophen Extra Strength Caplets
69676-0059-2	2025-01-30	Acetaminophen Extra Strength Caplets
69676-0059-5	2025-01-30	Acetaminophen Extra Strength Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69676-0059-2	Genexa AcetaminophenExtra Strength	100 in 1 BOTTLE	TABLET, COATED	100	7
69676-0059-2	Genexa AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
69676-0059-5	Genexa AcetaminophenExtra Strength	1 in 1 CARTON	TABLET, COATED	1	7
69676-0059-5	Genexa AcetaminophenExtra Strength	50 in 1 BOTTLE	TABLET, COATED	50	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69676-0059	GENEXA ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [GENEXA INC.]	5	Current NDC, Legacy NDC, 4 package rows	20250228_d6f968ca-719f-5a68-e053-2995a90a4afa.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 79 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief PM Extra Strength	ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	423a8445-964c-4cdb-889a-f391ca5253e7	2018-12-31	Warnings	Exact identifier application number: M013
Cold Multi-Symptom Night-time	ACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCI	Allegiant Health	3f020cf2-6011-4216-9b39-0b3dc5f0749c	2018-12-26	Warnings	Exact identifier application number: M013
Aspirin Chewable	ASPIRIN 81 MG	Allegiant Health	92b8637b-03a9-461f-b2f6-6eddaa214953	2018-12-21	Warnings	Exact identifier application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Allegiant Health	b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f	2018-12-21	Warnings	Exact identifier application number: M013
Clear Choice Regular Strength Pain Reliever	ACETAMINOPHEN	Athlete's Needs, Inc.	d0d9fda5-5eba-4d51-b505-e93a2ae0bdd7	2018-12-11	Warnings	Exact identifier application number: M013
ASPIRIN Enteric Coated	ASPIRIN 81 MG	Allegiant Health	5910a882-eb40-440f-8a30-c21fbce9050e	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN 325 MG	Allegiant Health	88b54062-8b3d-4024-a957-62b3255184b9	2018-11-07	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe5	2018-11-07	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	b431a1a3-39c4-4d6c-afdc-c8b017ad89da	2017-11-16	Warnings	Exact identifier application number: M013
SED-MAX	ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG	Command Brands, LLC	4920a0e9-6f88-4df0-8657-77c95a3b9617	2017-01-19	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	d6f968ca-719f-5a68-e053-2995a90a4afa	7
198440	acetaminophen 500 MG Oral Tablet	SCD	d6f968ca-719f-5a68-e053-2995a90a4afa	7
198440	APAP 500 MG Oral Tablet	SY	d6f968ca-719f-5a68-e053-2995a90a4afa	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69676-0059-2	69676005902	1 BOTTLE in 1 CARTON (69676-0059-2) / 100 TABLET, COATED in 1 BOTTLE	1 bottle	2022-02-17	0000-00-00	No	No	Current
69676-0059-5	69676005905	1 BOTTLE in 1 CARTON (69676-0059-5) / 50 TABLET, COATED in 1 BOTTLE	1 bottle	2022-02-17	0000-00-00	No	No	Current