berkley and jensen mucus relief dm

Generic: dextromethorphan hbr, guaifenesin

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen mucus relief dm
Generic Name dextromethorphan hbr, guaifenesin
Labeler bjwc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-812
Product ID 68391-812_c9e7328c-7360-4aba-b6bb-9b229ecbaee4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207602
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

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 68391812
Hyphenated Format 68391-812

Supplemental Identifiers

RxCUI
1099074
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 berkley and jensen mucus relief dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number ANDA207602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
  • 1200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68391-812-01) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68391-812-45) / 56 TABLET, EXTENDED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

68391-812-01 1 BOTTLE in 1 CARTON (68391-812-01) / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE 68391-812-45 1 BOTTLE in 1 CARTON (68391-812-45) / 56 TABLET, EXTENDED RELEASE in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Berkley and Jensen Mucus Relief DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c9e7328c-7360-4aba-b6bb-9b229ecbaee4", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["d3b94cce-e6f3-43ec-a927-7b7183744433"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68391-812-01)  / 84 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "68391-812-01", "marketing_start_date": "20250904"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68391-812-45)  / 56 TABLET, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "68391-812-45", "marketing_start_date": "20200715"}], "brand_name": "Berkley and Jensen Mucus Relief DM", "product_id": "68391-812_c9e7328c-7360-4aba-b6bb-9b229ecbaee4", "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": "68391-812", "generic_name": "dextromethorphan HBr, guaifenesin", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Berkley and Jensen Mucus Relief DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA207602", "marketing_category": "ANDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}