Premsyn pms Premenstrual Pain Relief
- Product NDC
- 71687-3102
- 11-digit product format
- 716873102
- Labeler code
- 71687
- Product ID
- 71687-3102_32bde825-4a2d-de16-e063-6394a90a7941
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Pamabrom and Pyrilamine maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Focus Consumer Healthcare, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-10-13
- Substance
- ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
- Active strength
- 500; 25; 15 mg/1; mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71687-3102-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71687-3102-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71687-3102-4 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71687-3102-4 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71687-3102-4 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71687-3102-4 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71687-3102-4 | U | Excluded because listing certification expired | 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
- Premsyn pms Premenstrual Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| PAMABROM | 25 mg/1 |
| PYRILAMINE MALEATE | 15 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| UA8U0KJM72 | Internal UNII lookup |
| R35D29L3ZA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71687-3102-4 | 2025-04-14 | C162847 | 48780-1 | 2cef2736-8f8b-d83d-e063-dadaa90ab31f | Premsyn pms Premenstrual Pain Relief |
| 71687-3102-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f8b-d83d-e063-dadaa90ab31f | Premsyn pms Premenstrual Pain Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71687-3102-4 | Premsyn pms Premenstrual Pain Relief | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | 8 | |
| 71687-3102-4 | Premsyn pms Premenstrual Pain Relief | 1 in 1 CARTON | TABLET | 1 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71687-3102 | PREMSYN PMS PREMENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250416_5b6f6260-69ae-cfeb-e053-2a91aa0a6b49.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 |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 0faa3592-4d56-4645-9a0e-066e0bdfebb6 | 2024-04-05 | Warnings | M013 |
| Pain Relief Childrens Dye Free | ACETAMINOPHEN | H E B | 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 | 2024-04-03 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | H E B | edb321dd-e5cb-4031-a8a8-efce9e86fe16 | 2024-04-03 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | H E B | a0c0277e-50aa-4328-8f93-ab20c6176b2b | 2024-04-03 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Bryant Ranch Prepack | bda805ab-7f37-405d-a144-4e06ad9a29a1 | 2024-04-03 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Family Dollar (FAMILY WELLNESS) | 650cb15e-c448-4df3-b0f8-4398be05d841 | 2024-03-27 | Warnings | M013 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052637 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | PSN | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052641 | Premsyn PMS 500 MG / 25 MG / 15 MG Oral Tablet | PSN | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052641 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet [Premsyn PMS] | SBD | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052637 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | SCD | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052637 | APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | SY | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052641 | APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Tablet [Premsyn PMS] | SY | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
| 1052641 | Premsyn PMS (APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG) Oral Tablet | SY | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71687-3102-4 | 71687310204 | 1 BOTTLE, PLASTIC in 1 CARTON (71687-3102-4) / 40 TABLET in 1 BOTTLE, PLASTIC | 2017-10-13 | 0000-00-00 | No | No | Current |