ACTIDOGESIC
- Product NDC
- 63102-402
- 11-digit product format
- 631020402
- Labeler code
- 63102
- Product ID
- 63102-402_abf1349b-a08e-4236-9b32-42a0e76e78a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dexbrompheniramine maleate, acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ACTIPHARMA, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-10-14
- Substance
- DEXBROMPHENIRAMINE MALEATE; ACETAMINOPHEN
- Active strength
- 1; 500 mg/1; mg/1
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63102-402-10 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63102-402-10 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63102-402-10 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63102-402-10 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63102-402-10 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63102-402-10 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63102-402-10 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63102-402-10 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63102-402-10 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63102-402-10 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 63102-402-10 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 63102-402-10 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 63102-402-10 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
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
- ACTIDOGESIC
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXBROMPHENIRAMINE MALEATE | 1 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| BPA9UT29BS | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1798453 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 697da3f9-9888-4d41-ba83-87ca9bf1e54b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63102-402-10 | 2024-08-06 | C162847 | 48780-1 | 0191ceaa-6363-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® |
| 63102-402-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6363-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-402-10 | ACTIDOGESIC | 100 in 1 BOTTLE | TABLET | 100 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-402-10 | EA - Each | 63102-402 | 7639ce03-04bd-412d-bb24-439b7f9419c4 | 1 | 2017-03-06 |
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 |
|---|---|---|---|---|---|---|
| Black Cherry Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f2e1a-2593-99e6-e053-2991aa0ad039 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857363b6-e025-e074-e053-2a91aa0a4379 | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 857365ba-895e-4a63-e053-2991aa0a8b9f | 2024-10-07 | Warnings | M012 |
| Menthol Vapor Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a7062db1-8201-b400-e053-2a95a90a55e8 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | b8f48a47-6871-f7ed-e053-2995a90a16f3 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 856f0bd8-354b-a002-e053-2a91aa0a8022 | 2024-10-07 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Boston Nutraceutical Production SL | 83c4928a-eea6-e176-e053-2991aa0a6bb1 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | c2340f56-9a8e-4eea-e053-2995a90a78fc | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | a706ee9c-9ed0-d3f1-e053-2a95a90a26d6 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff0b37b-6c08-b687-e053-2a95a90a11a9 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | efcf2edd-21a3-45f9-e053-2995a90a3865 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff65505-8846-35c2-e053-2a95a90a6b79 | 2024-10-07 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Topco Associates LLC | eff0fdfe-695a-4e62-e053-2a95a90ab50f | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff1a70f-fa71-52b2-e053-2995a90a038c | 2024-10-07 | Warnings | M012 |
| Honey Lemon Menthol Cough Drops | HONEY LEMON MENTHOL | Topco Associates LLC | f5be283b-524d-26af-e053-2995a90a3972 | 2024-10-07 | Warnings | M012 |
| Cough Drops | MENTHOL | Topco Associates LLC | eff16ba3-7e30-aa93-e053-2995a90a64cb | 2024-10-07 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | ebf6bcf5-9384-052a-e053-2a95a90a30a5 | 2024-10-07 | Warnings | M012 |
| Rompe Pecho SF Flu SF Flu | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06eac696-e8f6-ac50-e063-6394a90a2ed6 | 2024-10-07 | Warnings | M012 |
| dg health nasal four | PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ceeeb016-8e46-40b8-9923-8a4270475f45 | 2024-10-04 | Warnings | M012 |
| Topcare Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 99bc8829-167b-4cf8-8421-57da369f24cd | 2024-10-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1798453 | acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet | PSN | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 5 |
| 1798453 | acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral Tablet | SCD | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 5 |
| 1798453 | APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral Tablet | SY | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63102-402-10 | 63102040210 | 100 TABLET in 1 BOTTLE (63102-402-10) | 100 tablet | 2016-10-14 | 0000-00-00 | No | No | Current |