topcare calagesic

Generic: calamine and pramoxine hydrochloride lotion

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

Drug Facts

Product Profile

Brand Name topcare calagesic
Generic Name calamine and pramoxine hydrochloride lotion
Labeler topco associates llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

pramoxine hydrochloride 10 mg/mL, zinc oxide 80 mg/mL

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-268
Product ID 36800-268_0ccb3962-d499-0a6c-e063-6294a90a0d41
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2019-07-16

Pharmacologic Class

Classes
copper absorption inhibitor [epc] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800268
Hyphenated Format 36800-268

Supplemental Identifiers

RxCUI
1234532
UPC
0036800443419
UNII
88AYB867L5 SOI2LOH54Z

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 topcare calagesic (source: ndc)
Generic Name calamine and pramoxine hydrochloride lotion (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
  • 80 mg/mL
source: ndc
Packaging
  • 177 mL in 1 CONTAINER (36800-268-96)
source: ndc

Packages (1)

36800-268-96 177 mL in 1 CONTAINER (36800-268-96)

Ingredients (2)

pramoxine hydrochloride (10 mg/mL) zinc oxide (80 mg/mL)

Linked Drug Pages (1)

TopCare Calagesic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0ccb3962-d499-0a6c-e063-6294a90a0d41", "openfda": {"upc": ["0036800443419"], "unii": ["88AYB867L5", "SOI2LOH54Z"], "rxcui": ["1234532"], "spl_set_id": ["8dced3ea-147b-3d46-e053-2a95a90aa1c0"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 CONTAINER (36800-268-96)", "package_ndc": "36800-268-96", "marketing_start_date": "20190716"}], "brand_name": "TopCare Calagesic", "product_id": "36800-268_0ccb3962-d499-0a6c-e063-6294a90a0d41", "dosage_form": "LOTION", "pharm_class": ["Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]"], "product_ndc": "36800-268", "generic_name": "calamine and pramoxine hydrochloride lotion", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TopCare Calagesic", "active_ingredients": [{"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/mL"}, {"name": "ZINC OXIDE", "strength": "80 mg/mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190716", "listing_expiration_date": "20261231"}