severe cold and cough daytime

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Labeler: raritan pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name severe cold and cough daytime
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler raritan pharmaceuticals inc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, dextromethorphan hydrobromide 20 mg/1, phenylephrine hydrochloride 10 mg/1

Manufacturer
RARITAN PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 68163-540
Product ID 68163-540_3fc2f39e-6e41-a802-e063-6394a90a1cc5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-03-14

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68163540
Hyphenated Format 68163-540

Supplemental Identifiers

RxCUI
1659967
UPC
0368163540062
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ

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 severe cold and cough daytime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 20 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06)
source: ndc

Packages (1)

68163-540-06 6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06)

Ingredients (3)

acetaminophen (650 mg/1) dextromethorphan hydrobromide (20 mg/1) phenylephrine hydrochloride (10 mg/1)

Linked Drug Pages (1)

severe cold and cough daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fc2f39e-6e41-a802-e063-6394a90a1cc5", "openfda": {"upc": ["0368163540062"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1659967"], "spl_set_id": ["3ce8508e-7d9d-4413-858a-8f952e760c01"], "manufacturer_name": ["RARITAN PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POWDER, FOR SOLUTION in 1 CARTON (68163-540-06)", "package_ndc": "68163-540-06", "marketing_start_date": "20190314"}], "brand_name": "severe cold and cough daytime", "product_id": "68163-540_3fc2f39e-6e41-a802-e063-6394a90a1cc5", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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": "68163-540", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride", "labeler_name": "RARITAN PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "severe cold and cough", "brand_name_suffix": "daytime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190314", "listing_expiration_date": "20261231"}