rompe tos x children (69729-784)

Drug Facts

Product Profile

Brand Name rompe tos x children

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Labeler opmx llc

Dosage Form SYRUP

Routes

ORAL

Active Ingredients

acetaminophen 250 mg/10mL, dextromethorphan hydrobromide 13.33 mg/10mL, guaifenesin 200 mg/10mL, phenylephrine hydrochloride 5 mg/10mL

Manufacturer

OPMX LLC

Identifiers & Regulatory

Product NDC 69729-784

Product ID 69729-784_30b942ce-4452-9123-e063-6394a90ae60f

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 69729784

Hyphenated Format 69729-784

Supplemental Identifiers

RxCUI

1790651

UPC

0810053181331

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 children (source: ndc)

Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

250 mg/10mL
13.33 mg/10mL
200 mg/10mL
5 mg/10mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (1)

69729-784-06 1 BOTTLE, PLASTIC in 1 CARTON (69729-784-06) / 177 mL in 1 BOTTLE, PLASTIC

Ingredients (4)

acetaminophen (250 mg/10mL) dextromethorphan hydrobromide (13.33 mg/10mL) guaifenesin (200 mg/10mL) phenylephrine hydrochloride (5 mg/10mL)

Linked Drug Pages (1)

Rompe Tos X Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "30b942ce-4452-9123-e063-6394a90ae60f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0810053181331"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1790651"], "spl_set_id": ["05cc932d-b412-0710-e063-6394a90a87f6"], "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 (69729-784-06)  / 177 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69729-784-06", "marketing_start_date": "20230918"}], "brand_name": "Rompe Tos X Children", "product_id": "69729-784_30b942ce-4452-9123-e063-6394a90ae60f", "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": "69729-784", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "OPMX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rompe Tos X Children", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "13.33 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230918", "listing_expiration_date": "20261231"}