mucus relief dm extended release caplets

Generic: guaifenesin, dextromethorphan hbr

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mucus relief dm extended release caplets
Generic Name guaifenesin, dextromethorphan hbr
Labeler rugby laboratories
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/1, guaifenesin 600 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1161
Product ID 0536-1161_f6b72325-a048-4e79-ac83-aa61ae564f81
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209692
Listing Expiration 2027-12-31
Marketing Start 2018-12-13

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 05361161
Hyphenated Format 0536-1161

Supplemental Identifiers

RxCUI
1298324
UPC
0305361161378
UNII
9D2RTI9KYH 495W7451VQ
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 mucus relief dm extended release caplets (source: ndc)
Generic Name guaifenesin, dextromethorphan hbr (source: ndc)
Application Number ANDA209692 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
  • 600 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 40 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0536-1161-34 20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0536-1161-37 40 BLISTER PACK in 1 CARTON (0536-1161-37) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (30 mg/1) guaifenesin (600 mg/1)

Linked Drug Pages (1)

Mucus Relief DM Extended Release Caplets ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f6b72325-a048-4e79-ac83-aa61ae564f81", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0305361161378"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298324"], "spl_set_id": ["69cd399a-0103-4543-bb06-c7cccffe9cc4"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 CARTON (0536-1161-34)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1161-34", "marketing_end_date": "20270228", "marketing_start_date": "20181213"}, {"sample": false, "description": "40 BLISTER PACK in 1 CARTON (0536-1161-37)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0536-1161-37", "marketing_start_date": "20181213"}], "brand_name": "Mucus Relief DM Extended Release Caplets", "product_id": "0536-1161_f6b72325-a048-4e79-ac83-aa61ae564f81", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["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]"], "product_ndc": "0536-1161", "generic_name": "Guaifenesin, Dextromethorphan HBr", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief DM Extended Release Caplets", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/1"}, {"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA209692", "marketing_category": "ANDA", "marketing_start_date": "20181213", "listing_expiration_date": "20271231"}