coldtac plus

Generic: acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name coldtac plus
Generic Name acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide
Labeler opmx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-143
Product ID 69729-143_11d5d5ef-0f56-3fc6-e063-6294a90a368a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-01-05

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69729143
Hyphenated Format 69729-143

Supplemental Identifiers

RxCUI
1367204
UPC
0856828008571
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 plus (source: ndc)
Generic Name acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 6 POUCH in 1 PACKAGE (69729-143-06) / 2 TABLET in 1 POUCH (69729-143-02)
  • 72 POUCH in 1 PACKAGE (69729-143-72) / 2 TABLET in 1 POUCH (69729-143-02)
source: ndc

Packages (2)

69729-143-06 6 POUCH in 1 PACKAGE (69729-143-06) / 2 TABLET in 1 POUCH (69729-143-02) 69729-143-72 72 POUCH in 1 PACKAGE (69729-143-72) / 2 TABLET in 1 POUCH (69729-143-02)

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

COLDTAC Plus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11d5d5ef-0f56-3fc6-e063-6294a90a368a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0856828008571"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1367204"], "spl_set_id": ["3496866c-682f-420b-bfdb-64ecebbf70a2"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["OPMX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 PACKAGE (69729-143-06)  / 2 TABLET in 1 POUCH (69729-143-02)", "package_ndc": "69729-143-06", "marketing_start_date": "20180105"}, {"sample": false, "description": "72 POUCH in 1 PACKAGE (69729-143-72)  / 2 TABLET in 1 POUCH (69729-143-02)", "package_ndc": "69729-143-72", "marketing_start_date": "20180105"}], "brand_name": "COLDTAC Plus", "product_id": "69729-143_11d5d5ef-0f56-3fc6-e063-6294a90a368a", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69729-143", "generic_name": "Acetaminophen, Phenylephrin Hydrochloride, Dextromethorphan Hydrobromide", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COLDTAC Plus", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180105", "listing_expiration_date": "20261231"}