mixed berry sore throat lozenges

Generic: benzocaine

Labeler: topco associates
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mixed berry sore throat lozenges
Generic Name benzocaine
Labeler topco associates
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

benzocaine 7.5 mg/1, dextromethorphan hydrobromide 5 mg/1

Manufacturer
Topco Associates

Identifiers & Regulatory

Product NDC 36800-836
Product ID 36800-836_466f3fd5-c9e4-619b-e063-6294a90a5ec3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-08-03

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800836
Hyphenated Format 36800-836

Supplemental Identifiers

RxCUI
1039251
UPC
0036800418400
UNII
U3RSY48JW5 9D2RTI9KYH
NUI
N0000185508 N0000175629 N0000184306 M0000728

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 mixed berry sore throat lozenges (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 18 LOZENGE in 1 BLISTER PACK (36800-836-18)
source: ndc

Packages (1)

36800-836-18 18 LOZENGE in 1 BLISTER PACK (36800-836-18)

Ingredients (2)

benzocaine (7.5 mg/1) dextromethorphan hydrobromide (5 mg/1)

Linked Drug Pages (1)

Mixed Berry Sore Throat Lozenges ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "466f3fd5-c9e4-619b-e063-6294a90a5ec3", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0036800418400"], "unii": ["U3RSY48JW5", "9D2RTI9KYH"], "rxcui": ["1039251"], "spl_set_id": ["7a00c771-9231-e877-e053-2a91aa0ac96e"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Topco Associates"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 LOZENGE in 1 BLISTER PACK (36800-836-18)", "package_ndc": "36800-836-18", "marketing_start_date": "20180803"}], "brand_name": "Mixed Berry Sore Throat Lozenges", "product_id": "36800-836_466f3fd5-c9e4-619b-e063-6294a90a5ec3", "dosage_form": "LOZENGE", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Standardized Chemical Allergen [EPC]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "36800-836", "generic_name": "Benzocaine", "labeler_name": "Topco Associates", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mixed Berry Sore Throat Lozenges", "active_ingredients": [{"name": "BENZOCAINE", "strength": "7.5 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180803", "listing_expiration_date": "20261231"}