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 |
|---|---|---|---|---|---|---|
| Banophen | DIPHENHYDRAMINE HCL | A-S Medication Solutions | e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd | 2024-01-08 | Warnings | M012 |
| AXIM DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 0e7424ea-461f-5ead-e063-6294a90a41b6 | 2024-01-05 | Warnings | M012 |
| AXIM Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 0e740063-80d5-c48b-e063-6394a90a3b30 | 2024-01-05 | Warnings | M012 |
| AXIM DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 0e742e10-daea-6443-e063-6294a90ab5af | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 3c3e0dc8-cddd-4f46-9b68-19bac00c07cc | 2024-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | A-S Medication Solutions | fa12a5a8-bf2d-4991-9d54-9c519e8e04cd | 2024-01-04 | Warnings | M012 |
| NASAL DECONGESTANT PE 10mg | PHENYLPHRINE HCL | YYBA CORP | 05824fc4-ef3f-4ebb-b601-252f76ad60ef | 2024-01-03 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 5943d975-77e4-4cbd-b2d9-d699052fe82a | 2024-01-01 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Proficient Rx LP | ac79a7dd-c26e-47d2-8fb9-768d2d09e507 | 2024-01-01 | Warnings | M012 |
| Oxymethazoline HCL | OXYMETHAZOLINE HCL | Proficient Rx LP | 96883e5f-18b5-4c1c-b984-756cb86be6ff | 2024-01-01 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Proficient Rx LP | 6e91b9c3-57e8-488b-ac70-d863cdf9d6e8 | 2024-01-01 | Warnings | M012 |
| Good Neighbor Pharmacy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Proficient Rx LP | 9e067482-8735-4476-a82e-438dd24d4289 | 2024-01-01 | Warnings | M012 |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | AptaPharma Inc. | 94e02be4-b8a6-422a-8f66-e6a69e924b2c | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE | AptaPharma Inc. | 8a4c55d0-c472-4e89-9fdb-17ecf0af4856 | 2023-12-30 | Warnings | M012 |
| XL-3 Xtreme | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | AptaPharma Inc. | dff79e0b-edf0-4dd3-a722-fd9beecd6293 | 2023-12-30 | Warnings | M012 |
| TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Salado Sales, Inc. | e25727d0-7dd7-4ef5-b064-7938679f075f | 2023-12-29 | Warnings | M012 |
| Maximum Strength DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | bb56d09d-ecb0-469e-a16f-f9f1a48942a8 | 2023-12-29 | Warnings | M012 |
| Childrens Cough Mucus Relief | DEXTROMETHORPHANN HBR, GUAIFENESIN | Discount Drug Mart | 2c27aca4-e1e2-419a-84c4-857718ca49da | 2023-12-29 | Warnings | M012 |
| Night Time Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | de2b2e34-62a5-451f-ab68-531d1c9d4d82 | 2023-12-29 | Warnings | M012 |
| H E B MAX SEVERE CONGESTION and COUGH Maxium Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | d2b016ee-5329-45bf-9d71-d626204169cf | 2023-12-29 | 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 |