Acetaminophen PM
- Product NDC
- 55301-235
- 11-digit product format
- 553010235
- Labeler code
- 55301
- Product ID
- 55301-235_f7fb7025-847b-4902-97cd-ce5317267514
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ARMY AND AIR FORCE EXCHANGE SERVICE
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1994-05-15
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500; 25 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55301-235 | 55301-235-06 | D | Discontinued by firm | 2026-10-16 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55301-235 | 55301-235-06 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
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
- Acetaminophen PM
- Brand name suffix
- Extra Strength
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f1157dbc-d86c-4554-954c-60a74674ff6b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55301-235-06 | Acetaminophen PMExtra Strength | 200 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 200 | 13 | |
| 55301-235-15 | Acetaminophen PMExtra Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 13 | |
| 55301-235-15 | Acetaminophen PMExtra Strength | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55301-235 | ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE] | 12 | Current NDC, Legacy NDC, 3 package rows | 20241127_f1157dbc-d86c-4554-954c-60a74674ff6b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aspirin 81 mg Low Dose | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 23b29044-6389-42ea-839a-5351557a6ce3 | 2026-04-23 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a70867e-481d-4f01-9da3-d85663a1672e | 2026-04-23 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 07edcb31-d31d-4607-98c3-dcb1e062cc70 | 2026-04-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | ee50c5ee-1a61-4efc-aca9-42d897d6a3b8 | 2026-04-22 | Warnings | M013 |
| Aspirin | ASPIRIN | CVS PHARMACY | 904a2b21-d911-40c3-9e4b-59543ea5be4f | 2026-04-22 | Warnings | M013 |
| Pamprin Multi-Symptom Maximum Strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 60b3286d-5698-df50-e053-2991aa0afbe2 | 2026-04-20 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | CVS PHARMACY | af6fe4a9-2d18-4fed-b952-0a7866f65251 | 2026-04-20 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Preferred Pharmaceuticals Inc. | ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e | 2026-04-20 | Warnings | M013 |
| Parry-500mg Acetaminophen | ACETAMINOPHEN | MDC PHARMACEUTICALS LIMITED | fb07ba10-3210-41bc-9310-c952118fdcf3 | 2026-04-17 | Warnings | M013 |
| Aspirin NSAID | ASPIRIN | Valu Merchandisers Company | 0cc46a81-54c9-44b7-b384-79d25255eff2 | 2026-04-17 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Valu Merchandisers Company | 99de2c41-59b0-42e7-847e-e51229c6164f | 2026-04-17 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Walgreen Company | 1f3e2895-5ef7-4e6a-8d2e-b805d148f980 | 2026-04-16 | Warnings | M013 |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | b297aff8-a08b-4d37-b168-800a56564cbd | 2026-04-16 | Warnings | M013 |
| Childrens Tylenol | ACETAMINOPHEN | Kenvue Brands LLC | 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3 | 2026-04-16 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 8e65478b-7a7b-416c-b8e3-23dad79f8cc1 | 2026-04-16 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Valu Merchandisers Company | c9e384e5-fa9b-4c75-b5e3-16eb8db662ef | 2026-04-16 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | b6abfbbb-9826-4cd6-940f-3a314480a5a5 | 2026-04-15 | Warnings | M013 |
| Good Sense Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | f7137fe6-582e-43a4-8302-90ca54cd1de3 | 2026-04-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | e13656eb-513e-411e-bdae-35ff1ba7cfc1 | 2026-04-13 | Warnings | M013 |
| CareOne Acetaminophen | ACETAMINOPHEN | American Sales Company | b4f54465-3232-4685-9570-90be00876577 | 2026-04-12 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | f1157dbc-d86c-4554-954c-60a74674ff6b | 13 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | f1157dbc-d86c-4554-954c-60a74674ff6b | 13 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | f1157dbc-d86c-4554-954c-60a74674ff6b | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55301-235-06 | 55301023506 | 200 TABLET, FILM COATED in 1 BOTTLE (55301-235-06) | 1994-05-15 | 0000-00-00 | No | No | Current |
| 55301-235-15 | 55301023515 | 1 BOTTLE, PLASTIC in 1 CARTON (55301-235-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1994-05-15 | 0000-00-00 | No | No | Current |