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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 1d6c23d7-d1dc-4cba-8600-5762c18a0e27 | 2026-01-29 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Belmora LLC | 3622e072-2784-c57e-e063-6394a90a8217 | 2026-01-29 | Warnings, Adverse reactions | M012 |
| Night Time Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | e7dd763b-3005-4723-933b-171eb772afee | 2026-01-29 | Warnings | M012 |
| Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 24bc9ae6-8e8f-c0a0-e063-6394a90a407f | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | M012 |
| ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI | MEDWISE LIFESCIENCES INC. | 4970b8bc-3c7b-4b8a-e063-6294a90a7f1b | 2026-01-28 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Family Dollar (FAMILY WELLNESS) | fe3e74ba-31d9-4d50-ab61-ffb6aaa66085 | 2026-01-28 | Warnings | M012 |
| Leader Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. dba Leader | 9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5 | 2026-01-28 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02 | 2026-01-27 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 53a3e6a7-d625-4393-95eb-bb6f86e86cc1 | 2026-01-27 | Warnings | M012 |
| Dextromethorphan Hbr,Guaifenesin | DEXTROMETHORPHAN HBR,GUAIFENESIN | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2fbbfc7c-81a9-b647-e063-6394a90a55ac | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 32074a31-326b-4aaf-e063-6394a90a0d40 | 2026-01-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 335b6ddd-fdc8-1120-e063-6394a90add41 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | Warnings | M012 |
| Sunscreen SPF50 | NON NANO ZINC OXIDE | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI | c5d52f13-a649-9579-e053-2a95a90a062c | 2026-01-27 | Warnings | M012 |
| XL-3 Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rnv LLC | 03210929-331e-462d-b566-4e1865f52246 | 2026-01-27 | Warnings | M012 |
| XL-3 Day Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Rnv LLC | 2381ff41-4584-4b38-839f-f94e733f5bf2 | 2026-01-27 | 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 |