12 hour mucus relief (63868-149)

Drug Facts

Product Profile

Brand Name 12 hour mucus relief

Generic Name guaifenesin

Labeler chain drug marketing association inc

Dosage Form TABLET, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

guaifenesin 600 mg/1

Manufacturer

CHAIN DRUG MARKETING ASSOCIATION INC

Identifiers & Regulatory

Product NDC 63868-149

Product ID 63868-149_2435b323-730e-a3fb-e063-6294a90a7498

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA213420

Marketing Start 2021-09-17

Marketing End 2026-11-30

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 63868149

Hyphenated Format 63868-149

Supplemental Identifiers

RxCUI

636522

UNII

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 12 hour mucus relief (source: ndc)

Generic Name guaifenesin (source: ndc)

Application Number ANDA213420 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1

source: ndc

Packaging

2 BLISTER PACK in 1 CARTON (63868-149-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

source: ndc

Packages (1)

63868-149-20 2 BLISTER PACK in 1 CARTON (63868-149-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

guaifenesin (600 mg/1)

Linked Drug Pages (1)

12 Hour Mucus Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2435b323-730e-a3fb-e063-6294a90a7498", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ"], "rxcui": ["636522"], "spl_set_id": ["0d3b8e23-90d2-431b-a395-a9ddf2457e64"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63868-149-20)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "63868-149-20", "marketing_end_date": "20261130", "marketing_start_date": "20210917"}], "brand_name": "12 Hour Mucus Relief", "product_id": "63868-149_2435b323-730e-a3fb-e063-6294a90a7498", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]"], "product_ndc": "63868-149", "generic_name": "Guaifenesin", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "12 Hour Mucus Relief", "active_ingredients": [{"name": "GUAIFENESIN", "strength": "600 mg/1"}], "application_number": "ANDA213420", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20210917"}