Home NDC 0395-0420 Humco Calagesic
Product NDC 0395-0420
11-digit product format 003950420
Labeler code 0395
Product ID 0395-0420_101d12b5-fd3a-678d-e063-6294a90a64ea
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Pramoxine Hydrochloride
Dosage form LOTION
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Humco Calagesic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup 1234539 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-0420-96 Humco Calagesic 177 mL in 1 BOTTLE, PLASTIC LOTION 177 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0420 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231216_8c43590d-56ec-4588-8076-99ba94a16685.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 13 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Calamine CALAMINE 8%, ZINC OXIDE 8% Farmacias De Similares TX LLC 4ecd0add-11c9-cf3b-e063-6394a90adff6 2026-04-06 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM CVS Pharmacy, Inc. 4dc08832-e610-4e62-a6af-cadaa339e39e 2026-04-06 Warnings, Adverse reactions Exact identifier application number: M016 Witch Hazel WITCH HAZEL SPRAY CVS Pharmacy 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 2026-04-06 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Amazon.com Services LLC 616ef87d-1518-46aa-8e12-9a1b678d4980 2026-04-06 Warnings, Adverse reactions Exact identifier application number: M016 Stabilizing Repair Serum OATMEAL Dermalogica, LLC. 86b7b230-5424-46d3-8058-656f5172fc70 2026-04-02 Warnings Exact identifier application number: M016 calamine CALAMINE AND ZINC OXIDE STRATEGIC SOURCING SERVICES 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 2026-04-01 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream COLLOIDAL OATMEAL Kenvue Brands LLC 4e4e1797-26e6-a67b-e063-6294a90af438 2026-03-31 Warnings Exact identifier application number: M016 Target Advanced Scar Gel ADVANCED SCAR GEL Target Corporation 86c215fe-aad4-45d1-bdb7-cde00a115c5c 2026-03-31 Warnings Exact identifier application number: M016 Zinc oxide, Dimethicone ZINC OXIDE, DIMETHICONE Walmart Inc. 4cbf9492-33cd-e6d4-e063-6294a90ab001 2026-03-31 Warnings, Adverse reactions Exact identifier application number: M016 Critic-Aid Clear PETROLATUM Coloplast Corp a92c18f7-52b2-43e4-bae3-2bab9de22671 2026-03-31 Warnings Exact identifier application number: M016 3M Cavilon Durable Barrier DIMETHICONE Solventum US LLC f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 2026-03-31 Warnings Exact identifier application number: M016 XIMONTH Foot Sanitizer GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4e38d24d-3745-c121-e063-6394a90abbb5 2026-03-30 Warnings Exact identifier application number: M016 Dynashield ZINC OXIDE Dynarex Corporation 59fd865c-b81d-43ad-8fa0-c37ca0557769 2026-03-30 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant COLLOIDAL OATMEAL Port Jervis Laboratories, Inc 4e43b65c-d5bb-f228-e063-6294a90ad08d 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4275956d-275a-4e31-e063-6394a90a78d3 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42762471-e5cd-505e-e063-6294a90afb7d 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Variety Cherry-Strawberry-Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 450e46d2-de86-e5fa-e063-6294a90ac6ff 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512220a-9fc2-8816-e063-6394a90a9d15 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Original Military SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 45136b7e-136b-0283-e063-6394a90a599a 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-0420-96 00395042096 177 mL in 1 BOTTLE, PLASTIC (0395-0420-96) 177 ml 2017-11-13 0000-00-00 No No Current