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 |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e27b6637-ef32-44b5-a531-b6617d02fbbf | Available on FDA.report |
DailyMed Package Descriptions#
| 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Sense Effervescent Pain Relief | ASPIRIN | Perrigo Direct, Inc. | 103027a7-2f0e-8d8c-e063-6294a90aedc7 | 2024-03-26 | Warnings | M013 |
| rugby infants acetaminophen | ACETAMINOPHEN | Rugby Laboratories | 8aa9ac68-ca61-4163-a876-52034138c1ea | 2024-03-25 | Warnings | M013 |
| Equate Pain Reliever Acetaminophen for Adults 250 mg | ACETAMINOPHEN | Walmart Inc | 08a18481-f029-f01f-e063-6294a90aac65 | 2024-03-21 | Warnings | M013 |
| Equate Pain Reliever Acetaminophen for Adults 250 mg | ACETAMINOPHEN | Walmart Inc | 0d106fa2-2a77-deb2-e063-6394a90a2dac | 2024-03-21 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 872c5220-a379-4dc1-b99c-f11ebb82db35 | 2024-03-19 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 79886972-47a4-44c5-a131-1a691a328103 | 2024-03-19 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 5ffcc78d-9163-4cb4-8811-ae9f0142806a | 2024-03-18 | Warnings | M013 |
| ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER | ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER | HF Acquisition Co LLC, DBA HealthFirst | 13e621dc-b2b4-98fd-e063-6394a90acc75 | 2024-03-17 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS PHARMACY, INC | 097a9c98-a092-400d-9600-6797b0b9a50c | 2024-03-15 | Warnings | M013 |
| Excedrin PM Triple Action Caplets and Excedrin Tension Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | 978a9d27-6d41-42cb-a193-11314923d2ac | 2024-03-14 | Warnings | M013 |
| Excedrin PM Triple Action Caplets | ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | b3812d27-40af-40d7-864a-dfa4ae34cb9e | 2024-03-14 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 691b754c-bafc-47e2-a322-cf56245c01f6 | 2024-03-14 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS PHARMACY, INC | fdc80b2a-d7c1-4b3d-9a9b-28182c6320de | 2024-03-14 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 2cde052d-22a4-470f-8d6a-7c17061b8ac8 | 2024-03-14 | Warnings | M013 |
| Excedrin Tension Headache | ACETAMINOPHEN, CAFFEINE | Haleon US Holdings LLC | 12c074d1-81ac-47d2-8747-b018cda0058a | 2024-03-13 | Warnings | M013 |
| Menstrual Complete | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Strive Pharmaceuticals Inc. | 78c12459-3b27-4ed0-943d-520794eb438d | 2024-03-07 | Warnings | M013 |
| Pain Reliever fever Reducer Extra Strength | ACETAMINOPHEN | CVS Pharmacy | 7b5263ad-01b7-4fc5-9384-4da8efe89e35 | 2024-03-06 | Warnings | M013 |
| Excedrin Extra Strength Geltabs | ACETAMINOPHEN, ASPRIN, CAFFEINE | Haleon US Holdings LLC | 11a8439b-0159-4351-b0f5-fe7fad6a33c0 | 2024-03-05 | Warnings | M013 |
| Winco Foods Effervescent Pain Relief | ASPIRIN | Winco Foods, LLC | 128afdd7-a9d1-8957-e063-6294a90af569 | 2024-03-05 | Warnings | M013 |
| Aspirin Low Dose Safety Coated | ASPIRIN | Care One (Retail Business Services, LLC.) | 6659e103-fa03-4de0-af42-d2fbd548a87c | 2024-03-05 | Warnings | M013 |
DailyMed RxNorm Mappings#
| 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 | 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 |