BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN

Product NDC: 68391-411
11-digit product format: 683910411
Labeler code: 68391
Product ID: 68391-411_b0fb97e4-e927-4813-8133-c072fb4037f7
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: BJWC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-09-04
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
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: BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN
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
e27b6637-ef32-44b5-a531-b6617d02fbbf	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68391-411-79	BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	400 in 1 BOTTLE	TABLET, FILM COATED	400		2

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 78 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tri-Buffered Aspirin	ASPIRIN	Proficient Rx LP	640c3311-2abf-40b2-82b9-9fe4d8c1cf1d	2023-10-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CVS PHARMACY, INC	852e70e2-7279-6f33-e053-2991aa0a8676	2023-08-28	Warnings	Exact identifier application number: M013
Children Pain Relief	CHILDREN PAIN RELIEF	Allegiant Health	44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096	2023-07-17	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Better Living Brands LLC	4a76e898-3204-4f77-bc67-c19f5fe829f3	2023-07-05	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Lodaat LLC	04017bc9-602a-4204-96a9-b7f9713155f6	2023-01-31	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	WALGREENS	d71a22e8-9e39-a672-e053-2a95a90a1403	2022-07-08	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	PAIN RELIEF	Allegiant Health	d41d2319-8eed-4df9-813c-313497ceb8b4	2021-11-23	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	PAIN RELIEF PM	Allegiant Health	4c9969be-a01f-4ca4-800a-e404229ce28b	2021-11-23	Warnings	Exact identifier application number: M013
Tension Headache Relief	TENSION HEADACHE RELIEF	Allegiant Health	9d348550-060b-410f-8c1e-8f43d00b860e	2021-11-22	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	847fd2f8-2e32-4ef2-a793-b902045110f1	2021-11-19	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Allegiant Health	d6c7c8c9-b997-4acc-a066-133bfb1239cb	2021-11-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Delayed Release	ASPIRIN	Dr. Wayne's	eacbdf9e-5642-4986-a03c-b0812d28265d	2021-11-02	Warnings	Exact identifier application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen	ASPIRIN	Allegiant Health	d9abe780-7e58-43d8-848f-c6c8893aea2e	2021-10-14	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500MG	Allegiant Health	0f72be92-fac0-4be4-87a3-3f20f0f01db5	2021-05-17	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Westminster Pharmaceuticals, LLC	ace5ebac-ec11-4c26-b1e3-954b450ee671	2021-05-04	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated	ASPIRIN 81 MG	Allegiant Health	8cacf02c-9925-40d4-92bc-78788aa0681a	2020-11-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN 500 MG	Allegiant Health	8e60b78e-ef3c-4d44-b8d4-37cb8608a5c7	2020-03-13	Warnings	Exact identifier application number: M013
Acetaminophen 500mg ES	ACETAMINOPHEN 500MG	Allegiant Health	91acc132-01b6-467b-9af5-70f4dc93e087	2019-01-08	Warnings	Exact identifier application number: M013
Acetaminophen 325mg RS	ACETAMINOPHEN 325MG	Allegiant Health	61c6d281-e59b-4277-bbce-f71c12c2a56d	2019-01-07	Warnings	Exact identifier application number: M013
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Allegiant Health	9a4c0c43-a71a-4e22-a3d5-9eb9622689a2	2019-01-02	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	e27b6637-ef32-44b5-a531-b6617d02fbbf	2
198440	acetaminophen 500 MG Oral Tablet	SCD	e27b6637-ef32-44b5-a531-b6617d02fbbf	2
198440	APAP 500 MG Oral Tablet	SY	e27b6637-ef32-44b5-a531-b6617d02fbbf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68391-411-79	68391041179	400 TABLET, FILM COATED in 1 BOTTLE (68391-411-79)	2025-09-04	No	No	Current