safetussin pm nighttime cough relief

Generic: dextromethorphan hbr, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name safetussin pm nighttime cough relief
Generic Name dextromethorphan hbr, doxylamine succinate
Labeler kramer laboratories
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan 7.5 mg/5mL, doxylamine succinate 3.125 mg/5mL

Manufacturer
Kramer Laboratories

Identifiers & Regulatory

Product NDC 55505-221
Product ID 55505-221_b7fd290f-7f8e-430f-8bbf-b5aeea4181de
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-07-28

Pharmacologic Class

Established (EPC)
uncompetitive n-methyl-d-aspartate receptor antagonist [epc] sigma-1 agonist [epc]
Mechanism of Action
uncompetitive nmda receptor antagonists [moa] sigma-1 receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55505221
Hyphenated Format 55505-221

Supplemental Identifiers

RxCUI
1115329
UNII
7355X3ROTS V9BI9B5YI2
NUI
N0000181821 N0000182149 N0000181819 N0000182147

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 safetussin pm nighttime cough relief (source: ndc)
Generic Name dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/5mL
  • 3.125 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (55505-221-36) / 237 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

55505-221-36 1 BOTTLE, PLASTIC in 1 CARTON (55505-221-36) / 237 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan (7.5 mg/5mL) doxylamine succinate (3.125 mg/5mL)

Linked Drug Pages (1)

Safetussin PM Nighttime Cough relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b7fd290f-7f8e-430f-8bbf-b5aeea4181de", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147"], "unii": ["7355X3ROTS", "V9BI9B5YI2"], "rxcui": ["1115329"], "spl_set_id": ["33dd2245-9abd-4b32-ac76-0f45a54c0f33"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["Kramer Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (55505-221-36)  / 237 mL in 1 BOTTLE, PLASTIC", "package_ndc": "55505-221-36", "marketing_start_date": "20230728"}], "brand_name": "Safetussin PM Nighttime Cough relief", "product_id": "55505-221_b7fd290f-7f8e-430f-8bbf-b5aeea4181de", "dosage_form": "LIQUID", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "55505-221", "generic_name": "Dextromethorphan HBr, Doxylamine Succinate", "labeler_name": "Kramer Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Safetussin PM Nighttime", "brand_name_suffix": "Cough relief", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "7.5 mg/5mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "3.125 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230728", "listing_expiration_date": "20261231"}