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 |
|---|---|---|---|---|---|---|
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 721bfee2-0d3d-4d8b-beee-1ea83064d1c8 | 2024-01-23 | Warnings | M012 |
| Sugar Free Cough Drops Honey Lemon | MENTHOL | Cardinal Health 110, Inc. | fe90dc33-2815-8296-e053-6294a90ac1df | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Cardinal Health 110, Inc. | fe91543e-a798-6399-e053-6394a90af5e5 | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops Black Cherry | MENTHOL | Cardinal Health 110, Inc. | fe90cf63-d286-fa5e-e053-6394a90a7759 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol Honey Lemon | COUGH DROPS MENTHOL | Cardinal Health 110, Inc. | fe5b3f6d-2a2d-f322-e053-6394a90aba04 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol | MENTHOL COUGH DROPS | Cardinal Health 110, Inc. | fe5b557e-a689-a32c-e053-6294a90aadbd | 2024-01-19 | Warnings | M012 |
| Cough Drops Cherry | CHERRY FLAVOR COUGH DROPS | Cardinal Health 110, Inc. | fe5b5e57-1368-c62b-e053-6294a90ae82c | 2024-01-19 | Warnings | M012 |
| Leader Zinc Oxide | ZINC OXIDE | Cardinal Health 110,Inc. | 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 | 2024-01-18 | Warnings | M012 |
| Cough and Congestion DM Sugar Free | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 4656e60e-4733-45c1-bf55-d156e45085c6 | 2024-01-17 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Rugby Laboratories | 775f97c0-6f82-49a8-82ac-f1a73920c3ec | 2024-01-11 | Warnings | M012 |
| SinuFrin NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae | 2024-01-11 | Warnings | M012 |
| SinuFrin Plus NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals, Inc. | 99afe6a6-1350-49c6-9347-b7e531e35925 | 2024-01-11 | Warnings | M012 |
| Childrens Tukol Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 85fe6f0f-41c8-44d3-a34a-355938da5f72 | 2024-01-11 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | ad437177-08eb-4811-883f-ac543d5bc58c | 2024-01-11 | Warnings | M012 |
| Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | af5053d8-ba02-4cdf-877f-8c1e368dafe0 | 2024-01-10 | Warnings | M012 |
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | M012 |
| HISTEX-DM | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 836d062c-29f0-4fd7-b65c-771a3bbd52c4 | 2024-01-08 | 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 |