pediacare childrens cough and congestion grape

Generic: dextromethorphan hydrobromide and guaifenesin

Labeler: randob labs,ltd. dba crossingwell consumer health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pediacare childrens cough and congestion grape
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler randob labs,ltd. dba crossingwell consumer health
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH

Identifiers & Regulatory

Product NDC 52412-992
Product ID 52412-992_2a815f27-d222-bc77-e063-6294a90a5f7a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

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 52412992
Hyphenated Format 52412-992

Supplemental Identifiers

RxCUI
1020138
UPC
0030103092053
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 pediacare childrens cough and congestion grape (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

52412-992-01 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Pediacare Childrens Cough and Congestion Grape ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a815f27-d222-bc77-e063-6294a90a5f7a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0030103092053"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1020138"], "spl_set_id": ["9576723b-748c-45e7-bc0d-cc109b9f6735"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52412-992-01)  / 118 mL in 1 BOTTLE", "package_ndc": "52412-992-01", "marketing_start_date": "20230103"}], "brand_name": "Pediacare Childrens Cough and Congestion Grape", "product_id": "52412-992_2a815f27-d222-bc77-e063-6294a90a5f7a", "dosage_form": "SYRUP", "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": "52412-992", "generic_name": "DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN", "labeler_name": "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pediacare Childrens Cough and Congestion Grape", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}