FDA.reportPublic FDA data

REMEDY Calazime Skin Protectant

Product NDC
53329-165
11-digit product format
533290165
Labeler code
53329
Product ID
53329-165_2cdaa63c-2a2f-2fde-e063-6394a90a70c6
Type
HUMAN OTC DRUG
Nonproprietary name
calamine, menthol, white petrolatum, zinc oxide
Dosage form
PASTE
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-03-23
Substance
FERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE
Active strength
.5; .2; 69; 19.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
REMEDY Calazime Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERRIC OXIDE RED.5 g/100g
MENTHOL.2 g/100g
PETROLATUM69 g/100g
ZINC OXIDE19.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1K09F3G675, L7T10EIP3A, 4T6H12BN9U, SOI2LOH54Z
Rxcui1921772

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-165-022023-08-08C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant
53329-165-442023-08-08C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant
53329-165-962023-08-08C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant
53329-165-022023-07-28C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant
53329-165-442023-07-28C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant
53329-165-962023-07-28C16284748780-10191ceaa-6ed6-198a-e063-dbdaa90aec3e165 REMEDY Calazime Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-165-02REMEDY Calazime Skin Protectant3 in 1 BAGPASTE39
53329-165-44REMEDY Calazime Skin Protectant113 g in 1 TUBEPASTE1139
53329-165-96REMEDY Calazime Skin Protectant4 g in 1 PACKETPASTE49
53329-165-96REMEDY Calazime Skin Protectant144 in 1 BOXPASTE1449

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-165-44GM - Gram53329-165a485e81b-8b21-4e4e-83f9-8ba27da044a412013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ACETYLCYSTEINEINACTIVE INGREDIENTWYQ7N0BPYCREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
CITRUS MAXIMA FRUIT RIND OILINACTIVE INGREDIENT8U3877WD44REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
HYDROXYTYROSOLINACTIVE INGREDIENTQEU0NE4O90REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
VANILLININACTIVE INGREDIENTCHI530446XREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCREMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-165REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 4 package rows20250130_1295cfcc-5b61-481b-964b-f53ffd0cb58e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1921772calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical PastePSN1295cfcc-5b61-481b-964b-f53ffd0cb58e9
1921772calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG PasteSCD1295cfcc-5b61-481b-964b-f53ffd0cb58e9
1921772Calamine 0.035 MG/MG / Menthol 0.002 MG/MG / Petrolatum 0.69 MG/MG / ZNO 0.165 MG/MG PasteSY1295cfcc-5b61-481b-964b-f53ffd0cb58e9
1921772calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical PasteSY1295cfcc-5b61-481b-964b-f53ffd0cb58e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-165-02533290165023 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44) 3 tube2021-07-010000-00-00NoNoCurrent
53329-165-4453329016544113 g in 1 TUBE (53329-165-44) 113 g2018-03-140000-00-00NoNoCurrent
53329-165-9653329016596144 PACKET in 1 BOX (53329-165-96) > 4 g in 1 PACKET144 packet2018-03-140000-00-00NoNoCurrent