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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2771d699-3f70-4318-e063-6394a90a89cc | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b | 2025-12-09 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 5015a380-a229-4eff-8e31-528065c6ed64 | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | caf59320-5b48-4533-bda9-7b03a2fde0b5 | 2025-12-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 30d41dc3-e2ef-4cad-b63c-d634bc749aa1 | 2025-12-09 | Warnings | M012 |
| Walgreens Childrens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a7226-84b9-26d7-e063-6394a90a99b9 | 2025-12-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Meijer Distribution Inc | 8ed5b802-a26e-45b4-a696-bc64dbac4733 | 2025-12-09 | Warnings | M012 |
| dg health cold plus flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ff4a2f0a-d638-4ed2-8e05-2a52afbc4909 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 24894484-b834-4b2f-b365-c95b5e30d8bf | 2025-12-09 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Family Dollar (FAMILY WELLNESS) | 2c431220-c61b-4ad5-9ad2-58ccaee2d1c3 | 2025-12-09 | Warnings | M012 |
| Sinus PE Congestion Daytime Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9da77306-5098-4c79-845c-97ead849c84a | 2025-12-08 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fdd0dadc-5313-4f6e-aef5-ca853efe5c4d | 2025-12-08 | Warnings | M012 |
| Mucolyte | GUAIFENESIN | Rising Pharma Holdings, Inc. | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 2025-12-08 | Warnings | M012 |
| Mucolyte DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rising Pharma Holdings, Inc. | c913d27d-bc00-4ace-9a5f-c55522e1cd1d | 2025-12-08 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | American Sales | 47f504d5-3ec5-5227-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | American Sales | 4893ac0a-7769-5657-e054-00144ff8d46c | 2025-12-07 | Warnings | M012 |
| Cherry cough drop | MENTHOL | American Sales | 45e891ea-2f2a-31b7-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Cherry Sore Throat Lozenge | BENZOCAINE | American Sales | 49248a40-1ca3-6dd1-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | American Sales | 4896cbd1-57dd-1fc6-e054-00144ff8d46c | 2025-12-07 | 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 |