coldtac ultra

Generic: acetaminophen, chlorpheniramine maleate, phenylephrine hcl

Labeler: opmx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name coldtac ultra
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hcl
Labeler opmx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, chlorpheniramine maleate 4 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-133
Product ID 69729-133_0fe1dc7c-42ec-a74f-e063-6294a90a536c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-01-10

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69729133
Hyphenated Format 69729-133

Supplemental Identifiers

RxCUI
2463332
UPC
0856828008427 0810053181256 0856828008410 0856828008151
UNII
362O9ITL9D V1Q0O9OJ9Z 04JA59TNSJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name coldtac ultra (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 4 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH
  • 2 TABLET in 1 POUCH (69729-133-27)
  • 6 POUCH in 1 CARTON (69729-133-37) / 2 TABLET in 1 POUCH
  • 72 POUCH in 1 CARTON (69729-133-38) / 2 TABLET in 1 POUCH
source: ndc

Packages (4)

69729-133-06 3 POUCH in 1 CARTON (69729-133-06) / 2 TABLET in 1 POUCH 69729-133-27 2 TABLET in 1 POUCH (69729-133-27) 69729-133-37 6 POUCH in 1 CARTON (69729-133-37) / 2 TABLET in 1 POUCH 69729-133-38 72 POUCH in 1 CARTON (69729-133-38) / 2 TABLET in 1 POUCH

Ingredients (3)

acetaminophen (500 mg/1) chlorpheniramine maleate (4 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

COLDTAC ULTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0fe1dc7c-42ec-a74f-e063-6294a90a536c", "openfda": {"upc": ["0856828008427", "0810053181256", "0856828008410", "0856828008151"], "unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ"], "rxcui": ["2463332"], "spl_set_id": ["0e9d506d-8c0c-ab6b-e063-6294a90a5ab6"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (69729-133-06)  / 2 TABLET in 1 POUCH", "package_ndc": "69729-133-06", "marketing_start_date": "20240110"}, {"sample": false, "description": "2 TABLET in 1 POUCH (69729-133-27)", "package_ndc": "69729-133-27", "marketing_start_date": "20240110"}, {"sample": false, "description": "6 POUCH in 1 CARTON (69729-133-37)  / 2 TABLET in 1 POUCH", "package_ndc": "69729-133-37", "marketing_start_date": "20240110"}, {"sample": false, "description": "72 POUCH in 1 CARTON (69729-133-38)  / 2 TABLET in 1 POUCH", "package_ndc": "69729-133-38", "marketing_start_date": "20240110"}], "brand_name": "COLDTAC ULTRA", "product_id": "69729-133_0fe1dc7c-42ec-a74f-e063-6294a90a536c", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69729-133", "generic_name": "Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLDTAC ULTRA", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "4 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240110", "listing_expiration_date": "20261231"}