Home NDC 53329-165 REMEDY Calazime Skin Protectant
Product NDC 53329-165
11-digit product format 533290165
Labeler code 53329
Product ID 53329-165_42658b90-1277-f5db-e063-6294a90a2460
Type HUMAN OTC DRUG
Nonproprietary name calamine, menthol, white petrolatum, zinc oxide
Dosage form PASTE
Route TOPICAL
Labeler Medline Industries, LP
Application M015
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-23
Marketing end 2027-07-01
Substance FERRIC OXIDE RED; MENTHOL; ZINC OXIDE; PETROLATUM
Active strength .5; .2; 19.5; 69 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 REMEDY Calazime Skin Protectant Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED .5 g/100g MENTHOL .2 g/100g ZINC OXIDE 19.5 g/100g PETROLATUM 69 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1921772 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-165-02 REMEDY Calazime Skin Protectant 3 in 1 BAG PASTE 3 9 53329-165-44 REMEDY Calazime Skin Protectant 113 g in 1 TUBE PASTE 113 9 53329-165-96 REMEDY Calazime Skin Protectant 4 g in 1 PACKET PASTE 4 9 53329-165-96 REMEDY Calazime Skin Protectant 144 in 1 BOX PASTE 144 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 MENTHOL ACTIVE INGREDIENT L7T10EIP3A REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 PETROLATUM ACTIVE INGREDIENT 4T6H12BN9U REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 PETROLATUM ACTIVE MOIETY 4T6H12BN9U REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 .ALPHA.-TOCOPHEROL INACTIVE INGREDIENT H4N855PNZ1 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ACETYLCYSTEINE INACTIVE INGREDIENT WYQ7N0BPYC REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 CITRUS MAXIMA FRUIT RIND OIL INACTIVE INGREDIENT 8U3877WD44 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 CORN OIL INACTIVE INGREDIENT 8470G57WFM REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 HYDROXYTYROSOL INACTIVE INGREDIENT QEU0NE4O90 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) INACTIVE INGREDIENT 461P5CJN6T REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 ORANGE OIL INACTIVE INGREDIENT AKN3KSD11B REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 PYRIDOXINE HYDROCHLORIDE INACTIVE INGREDIENT 68Y4CF58BV REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 SAFFLOWER OIL INACTIVE INGREDIENT 65UEH262IS REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 VANILLIN INACTIVE INGREDIENT CHI530446X REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-165 REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP] 9 Current NDC, Legacy NDC, 4 package rows 20250130_1295cfcc-5b61-481b-964b-f53ffd0cb58e.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 2 of 23 · 441 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Numb520Spray LIDOCAINE, PHENYLEPHRINE HCL Ebanel Laboratories, Inc. 350f0e25-fbdc-c0c0-e063-6294a90a50a0 2026-08-20 Warnings Exact identifier application number: M015 Gembooxt Topical Numbing Cream LIDOCAINE Guangdong Quadrant Ecological Technology Co., Ltd. 49951a3e-3b62-3d66-e063-6294a90a9360 2026-08-12 Warnings Exact identifier application number: M015 NumbMD Lidocaine Cream Anorectal(hemorrhoidal) LIDOCAINE 5% EveryMarket Inc 52379055-d017-4d98-e063-6294a90a196c 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 52369a41-820d-cd7a-e063-6394a90ac6d1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD Lidocaine Cream LIDOCAINE 5% EveryMarket Inc 51d370b4-1c34-d203-e063-6394a90a80b1 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD 5% Lidocaine cream LIDOCAINE 5% EveryMarket Inc 507d0c2c-9517-40f8-e063-6394a90a1996 2026-08-12 Warnings Exact identifier application number: M015 Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) LIDOCAINE CREAM ANORECTAL EveryMarket Inc 483d81a3-7493-3391-e063-6394a90a2e3d 2026-08-12 Warnings Exact identifier application number: M015 Numbing Cream LIDOCAINE 100 KARMA INC 35b5ba9d-da1d-55d6-e063-6294a90a5fa8 2026-08-12 Warnings Exact identifier application number: M015 Treatonic hemorrhoid treatment 5% LIDOCAINE 100 KARMA INC 41442fa7-c511-07ca-e063-6294a90a3992 2026-08-12 Warnings Exact identifier application number: M015 Lidocaine numbing cream 5% LIDOCAINE 100 KARMA INC 47380721-6633-4a50-e063-6394a90aca94 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 47dc7630-9a74-1989-e063-6294a90a50bb 2026-08-12 Warnings Exact identifier application number: M015 Treatonic 5% Lidocaine Cream 5% LIDOCAINE CREAM 100 KARMA INC 49e6b69f-bd6e-b415-e063-6394a90a8e65 2026-08-12 Warnings Exact identifier application number: M015 Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing LIDOCAINE Putian Licheng District Zhijiancheng Trading Co., Ltd. 4a7be9eb-5e57-90e8-e063-6394a90aad9e 2026-08-08 Warnings Exact identifier application number: M015 THE SOLU TION LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDE SCALP TECH INC 58793581-8826-9a74-e063-6294a90a2465 2026-08-06 Warnings Exact identifier application number: M015 Lidocaine Numbing Cream LIDOCAINE Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. 5457b3d7-e6b6-34a7-e063-6394a90aa240 2026-08-03 Warnings Exact identifier application number: M015 HEMORRHOIDALCREAMPROCURE PHENYLEPHRINE HCL, PETROLATUM, MINERAL OIL TWIN MED, LLC e9c44756-1c98-41be-e053-2995a90a35b4 2026-08-03 Warnings Exact identifier application number: M015 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE YYBA CORP 582a0001-da1e-909a-e063-6394a90a2b11 2026-08-03 Warnings Exact identifier application number: M015 up and up PHENYLEPHRINE HYDROCHLORIDE Target Corporation b42775ae-44fe-487e-b9ca-21d9687020a9 2026-07-29 Warnings Exact identifier application number: M015 Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 578fa642-ff30-e511-e063-6294a90a5987 2026-07-26 Warnings Exact identifier application number: M015 CVS Topical Anesthetic Hemorrhoidal DIBUCAINE CVS PHARMACY, INC 9f3d4fdb-ad82-4ab8-8a9e-252d027068ab 2026-07-25 Warnings Exact identifier application number: M015
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 53329-165-02 53329016502 3 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44) 3 tube 2021-07-01 2027-07-01 No No Current 53329-165-44 53329016544 113 g in 1 TUBE (53329-165-44) 113 g 2018-03-14 2027-07-01 No No Current 53329-165-96 53329016596 144 PACKET in 1 BOX (53329-165-96) > 4 g in 1 PACKET 144 packet 2018-03-14 0000-00-00 No No Current