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 |
|---|---|---|---|---|---|---|
| Childrens Mucus Relief Cough Cherry Liquid | DEXTROMETHORPHAN HBR, GUAIFENSIN | Topco Associates | 3170748e-b09f-4c07-9927-df43771166c5 | 2025-12-16 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | ca6d43cf-0d1f-4d3c-be7e-e3ac6a24f4fe | 2025-12-16 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | e70d0784-53bc-4910-aade-3c9ad6e36441 | 2025-12-16 | Warnings | M012 |
| Pain and Sinus | ACETAMINOPHEN AND PHENYLEPHRINE | JHK Inc dba American Safety & First Aid | 88f86f5a-cc2b-4c75-b7a4-f2021922280b | 2025-12-16 | Warnings | M012 |
| Severe Congestion and Cough, Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 2025-12-16 | Warnings | M012 |
| Cough Relief Nighttime | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fe5fd29e-7f81-4633-8c3b-010d68abe701 | 2025-12-16 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | e0a62fa1-9f8a-4770-b28b-1f4f02a762e0 | 2025-12-16 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 8c4b59b8-dfab-4f4a-9966-f07b026a758a | 2025-12-16 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | QUALITY CHOICE (Chain Drug Marketing Association) | df866cf6-0526-4e61-ac9b-245b57dd5df6 | 2025-12-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | c89200b6-4adb-452e-b931-07f631dad641 | 2025-12-16 | Warnings | M012 |
| ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 45fa9159-d74c-063a-e063-6294a90a3ed0 | 2025-12-15 | Warnings | M012 |
| SudoGest Nasal Decongestant | PSEUDOEPHEDRINE HCL | Major Pharmaceuticals | 5229f4b2-a194-46f8-a0bc-4510fbe52075 | 2025-12-15 | Warnings | M012 |
| Topcare Nasal | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f2b2467f-2d9b-4742-b90a-95975c3b694f | 2025-12-13 | Warnings | M012 |
| Menthol Cough Drop | MENTHOL | HEB | 39178eb7-ada9-30bf-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| SF Menthol Cough Drop | MENTHOL | HEB | 3a443179-b7a6-3242-e054-00144ff8d46c | 2025-12-13 | Warnings | M012 |
| Cherry cough drop | MENTHOL | HEB | 39bd0ca1-348f-0ce1-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| Strawberry Cough Drops | MENTHOL | HEB | 766236e2-3302-2232-e053-2991aa0af503 | 2025-12-13 | Warnings | M012 |
| Honey Lemon Cough Drop | MENTHOL | HEB | 3a30a427-6ab4-24ae-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough Lozenges | BENZOCAINE | HEB | 3063ea93-6bc2-1d18-e054-00144ff88e88 | 2025-12-13 | Warnings | M012 |
| HEB Menthol Cough Drops | MENTHOL | HEB | c197855d-15b4-38fc-e053-2a95a90a2dc7 | 2025-12-13 | 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 |