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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-16553329-165-96DDiscontinued by firm2026-10-15

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.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553329-165-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653329-165-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3153329-165-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2853329-165-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2153329-165-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1053329-165-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3153329-165-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2053329-165-44ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2053329-165-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1053329-165-440efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1053329-165-960efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0853329-165-96ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-165-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0353329-165-96367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-165-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0953329-165-96557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-165-44557ba5c1ecfa…9c80585c8c6e…

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
IngredientStrength
FERRIC OXIDE RED.5 g/100g
MENTHOL.2 g/100g
ZINC OXIDE19.5 g/100g
PETROLATUM69 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1K09F3G675Internal UNII lookup
L7T10EIP3AInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1921772Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1295cfcc-5b61-481b-964b-f53ffd0cb58eAvailable on FDA.report

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#

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

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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact identifier
application number: M015

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 tube2021-07-012027-07-01NoNoCurrent
53329-165-4453329016544113 g in 1 TUBE (53329-165-44) 113 g2018-03-142027-07-01NoNoCurrent
53329-165-9653329016596144 PACKET in 1 BOX (53329-165-96) > 4 g in 1 PACKET144 packet2018-03-140000-00-00NoNoCurrent