COLDTAC ULTRA
- Product NDC
- 69729-133
- 11-digit product format
- 697290133
- Labeler code
- 69729
- Product ID
- 69729-133_5d1ffdea-dd95-21e2-e063-6294a90a0bbe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-10
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
- Active strength
- 10; 500; 4 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- COLDTAC ULTRA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-133-06 | COLDTAC ULTRA | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 69729-133-06 | COLDTAC ULTRA | 3 in 1 CARTON | TABLET | 3 | 2 | |
| 69729-133-27 | COLDTAC ULTRA | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 69729-133-37 | COLDTAC ULTRA | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 69729-133-37 | COLDTAC ULTRA | 6 in 1 CARTON | TABLET | 6 | 2 | |
| 69729-133-38 | COLDTAC ULTRA | 72 in 1 CARTON | TABLET | 72 | 2 | |
| 69729-133-38 | COLDTAC ULTRA | 2 in 1 POUCH | TABLET | 2 | 2 |
DailyMed Dashboard NDC Coverage#
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 Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORP | 0b1e230d-4354-bf61-e063-6394a90a2b2f | 2023-12-09 | Warnings | M012 |
| Phenylephrine HCl Maximum Strength | PHENYLEPHRINE HCL | A-S Medication Solutions | fcb769d0-aa45-48eb-acd0-2247b392f9fe | 2023-12-09 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf915af-a016-0a46-e063-6394a90aacf5 | 2023-12-08 | Warnings | M012 |
| Maximum Strength Daytime Severe and Nighttime Cold and Flu | DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI | TARGET Corporation | 0bf9c0df-7676-3060-e063-6394a90a16c7 | 2023-12-08 | Warnings | M012 |
| Nazal | NAPHAZOLINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 4d4043f8-5ed3-4027-beb6-687db1308202 | 2023-12-06 | Warnings | M012 |
| Family Wellness Oxymetazoline | OXYMETAZOLINE | FAMILY DOLLAR (Family Wellness) | 8b4557d4-74a0-400f-ad7a-6d31473b3c67 | 2023-12-06 | Warnings | M012 |
| Childrens Plus Flu | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 1598e6f8-08ee-4216-a5ab-76cad37b09a7 | 2023-12-06 | Warnings | M012 |
| Welmedix HomeCare PRO Fragile Skin Protectant | PETROLATUM | Welmedix LLC | 6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf | 2023-12-05 | Warnings | M012 |
| Welmedix HomeCare PRO Extra Strength Rapid Rash Relief | PETROLATUM, ZINC OXIDE | Welmedix LLC | 551e6cce-7adc-4e98-baff-2703b83d7526 | 2023-12-05 | Warnings | M012 |
| Stona-S | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | 2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1 | 2023-12-04 | Warnings | M012 |
| Stona Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Sato Pharmaceutical Co., Ltd. | afc95c82-18da-487b-b4bb-51e0be0378da | 2023-12-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | Walgreens Company | a14643a1-3d91-491a-88d6-22dccde97938 | 2023-12-04 | Warnings | M012 |
| TopCare Day Time SEVERE Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 14d53907-a4a2-4a0f-b2d6-33474945f9e1 | 2023-12-04 | Warnings | M012 |
| Banophen | DIPHENHYDRAMINE HCL | Proficient Rx LP | 62934d0f-b23d-4c03-9d60-a7bad41f9b42 | 2023-12-01 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | b1c849e5-8003-4fd3-811d-6a927523e353 | 2023-12-01 | Warnings | M012 |
| Akin Expectorant Formula Strawberry Banana | GUAIFENESIN | Southern Sales & Service, Inc. | b63b0133-d2da-432b-a154-9e77535bbef9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM Strawberry Banana | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Southern Sales & Service, Inc. | 7a81efd8-775d-455e-860f-f3e3b369a0a7 | 2023-11-29 | Warnings | M012 |
| Akin | GUAIFENESIN | Southern Sales & Service, Inc. | bb2c9f21-6765-4286-bd71-de01cdf4c4e9 | 2023-11-29 | Warnings | M012 |
| Akin Cough Formula DM | DEXTROMETHORPHAN, GUAIFENESIN | Southern Sales & Service, Inc. | 1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a | 2023-11-29 | Warnings | M012 |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Simpex Pharma Pvt. Ltd | 82771f6a-8b3d-4ffa-8b35-09c2faf3582c | 2023-11-29 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2463332 | acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet | PSN | 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6 | 2 |
| 2463332 | acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SCD | 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6 | 2 |
| 2463332 | APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet | SY | 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69729-133-06 | 69729013306 | 3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH | 3 pouch | 2024-01-10 | No | No | Current |
| 69729-133-27 | 69729013327 | 2 TABLET in 1 POUCH (69729-133-27) | 2 tablet | 2024-01-10 | No | No | Current |
| 69729-133-37 | 69729013337 | 6 POUCH in 1 CARTON (69729-133-37) / 2 TABLET in 1 POUCH | 6 pouch | 2024-01-10 | No | No | Current |
| 69729-133-38 | 69729013338 | 72 POUCH in 1 CARTON (69729-133-38) / 2 TABLET in 1 POUCH | 72 pouch | 2024-01-10 | No | No | Current |
| 69729-133-50 | 69729013350 | 50 POUCH in 1 CARTON (69729-133-50) / 2 TABLET in 1 POUCH | 50 pouch | 2026-07-23 | No | No | Current |