desresfriol-dx softgels

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name desresfriol-dx softgels
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler opmx llc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
OPMX LLC.

Identifiers & Regulatory

Product NDC 69729-121
Product ID 69729-121_155f7122-feb9-c81f-e063-6294a90ab72d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69729121
Hyphenated Format 69729-121

Supplemental Identifiers

RxCUI
1086997
UPC
0810053180723
UNII
362O9ITL9D 9D2RTI9KYH 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 desresfriol-dx softgels (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69729-121-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

69729-121-10 1 BLISTER PACK in 1 CARTON (69729-121-10) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Desresfriol-DX Softgels ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "155f7122-feb9-c81f-e063-6294a90ab72d", "openfda": {"upc": ["0810053180723"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["ff5e0e0f-bfd2-b02b-e053-6394a90afe8a"], "manufacturer_name": ["OPMX LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69729-121-10)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69729-121-10", "marketing_start_date": "20230630"}], "brand_name": "Desresfriol-DX Softgels", "product_id": "69729-121_155f7122-feb9-c81f-e063-6294a90ab72d", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "69729-121", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride", "labeler_name": "OPMX LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Desresfriol-DX Softgels", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}