Tylenol PM
- Product NDC
- 73097-013
- 11-digit product format
- 730970013
- Labeler code
- 73097
- Product ID
- 73097-013_518f65e6-62bf-d778-e063-6394a90a67de
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Savings Distributors LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-22
- 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
- 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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 73097-013-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 73097-013-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 73097-013-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 73097-013-40 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 73097-013-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 73097-013-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 73097-013-40 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 73097-013-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 73097-013-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 73097-013-40 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 73097-013-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 73097-013-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 73097-013-40 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 73097-013-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 73097-013-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 73097-013-40 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 73097-013-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 73097-013-50 | cdf11ea48f46… | ba0047e9e063… |
| 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 | 73097-013-40 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 73097-013-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 73097-013-50 | 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 | 73097-013-40 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 73097-013-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 73097-013-50 | 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 | 73097-013-40 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 73097-013-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 73097-013-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 73097-013-40 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 73097-013-02 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 73097-013-50 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 73097-013-40 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 73097-013-02 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 73097-013-50 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 73097-013-40 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 73097-013-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 73097-013-50 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 73097-013-40 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 73097-013-02 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 73097-013-50 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 73097-013-40 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 73097-013-02 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 73097-013-50 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 73097-013-40 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 73097-013-02 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 73097-013-50 | 1332a3947898… | d4bfe170f9cd… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tylenol PM
- Listing expiration
- 2027-12-31
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#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73097-013-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-cd9d-0266-e053-dadaa90a7c1a | Tylenol PM |
| 73097-013-40 | 2023-01-30 | C162847 | 48780-1 | f386c649-cd9d-0266-e053-dadaa90a7c1a | Tylenol PM |
| 73097-013-50 | 2023-01-30 | C162847 | 48780-1 | f386c649-cd9d-0266-e053-dadaa90a7c1a | Tylenol PM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73097-013-02 | Tylenol PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 73097-013-02 | Tylenol PM | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 73097-013-40 | Tylenol PM | 20 in 1 CARTON | TABLET, FILM COATED | 20 | 3 | |
| 73097-013-40 | Tylenol PM | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 | |
| 73097-013-50 | Tylenol PM | 25 in 1 CARTON | TABLET, FILM COATED | 25 | 3 | |
| 73097-013-50 | Tylenol PM | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 3 |
DailyMed Dashboard NDC Coverage#
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092378 | Tylenol PM 500 MG / 25 MG Oral Tablet | PSN | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092378 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM] | SBD | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092378 | APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM] | SY | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092378 | Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet | SY | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
| 1092378 | Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet | SY | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 73097-013-02 | 73097001302 | 1 POUCH in 1 CARTON (73097-013-02) / 2 TABLET, FILM COATED in 1 POUCH | 1 pouch | 2019-07-22 | 0000-00-00 | No | No | Current |
| 73097-013-40 | 73097001340 | 20 POUCH in 1 CARTON (73097-013-40) / 2 TABLET, FILM COATED in 1 POUCH | 20 pouch | 2019-07-22 | 0000-00-00 | No | No | Current |
| 73097-013-50 | 73097001350 | 25 POUCH in 1 CARTON (73097-013-50) / 2 TABLET, FILM COATED in 1 POUCH | 25 pouch | 2019-07-22 | 0000-00-00 | No | No | Current |