rompe tos x adults

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name rompe tos x adults
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler opmx llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/20mL, dextromethorphan hydrobromide 26.66 mg/20mL, guaifenesin 400 mg/20mL, phenylephrine hydrochloride 10 mg/20mL

Manufacturer
OPMX LLC

Identifiers & Regulatory

Product NDC 69729-785
Product ID 69729-785_30b94710-9f43-fc1e-e063-6294a90a8e9e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-09-18

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 69729785
Hyphenated Format 69729-785

Supplemental Identifiers

RxCUI
1790651
UPC
0810053181348
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 rompe tos x adults (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
  • 26.66 mg/20mL
  • 400 mg/20mL
  • 10 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06) / 177 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69729-785-06 1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06) / 177 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (500 mg/20mL) dextromethorphan hydrobromide (26.66 mg/20mL) guaifenesin (400 mg/20mL) phenylephrine hydrochloride (10 mg/20mL)

Linked Drug Pages (1)

Rompe Tos X Adults ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30b94710-9f43-fc1e-e063-6294a90a8e9e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0810053181348"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1790651"], "spl_set_id": ["05abb2db-d22e-90b5-e063-6294a90ace3f"], "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": "1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06)  / 177 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69729-785-06", "marketing_start_date": "20230918"}], "brand_name": "Rompe Tos X Adults", "product_id": "69729-785_30b94710-9f43-fc1e-e063-6294a90a8e9e", "dosage_form": "SYRUP", "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": "69729-785", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Tos X Adults", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "26.66 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230918", "listing_expiration_date": "20261231"}