supress dx pediatric drops

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name supress dx pediatric drops
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/mL, guaifenesin 50 mg/mL, phenylephrine hydrochloride 2.5 mg/mL

Manufacturer
KRAMER NOVIS

Identifiers & Regulatory

Product NDC 52083-055
Product ID 52083-055_dc1e71f8-2a20-4968-b4ad-00c19b3d0dec
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-03-29

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 52083055
Hyphenated Format 52083-055

Supplemental Identifiers

RxCUI
1095503
UPC
0352083055010
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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 supress dx pediatric drops (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 50 mg/mL
  • 2.5 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (52083-055-01)
source: ndc

Packages (1)

52083-055-01 30 mL in 1 BOTTLE (52083-055-01)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/mL) guaifenesin (50 mg/mL) phenylephrine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Supress DX Pediatric Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dc1e71f8-2a20-4968-b4ad-00c19b3d0dec", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083055010"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1095503"], "spl_set_id": ["ddb95436-7806-4086-af4d-18a6625b5c83"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["KRAMER NOVIS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (52083-055-01)", "package_ndc": "52083-055-01", "marketing_start_date": "20110329"}], "brand_name": "Supress DX Pediatric Drops", "product_id": "52083-055_dc1e71f8-2a20-4968-b4ad-00c19b3d0dec", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "52083-055", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride", "labeler_name": "KRAMER NOVIS", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Supress DX Pediatric Drops", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110329", "listing_expiration_date": "20261231"}