FDA.reportPublic FDA data

calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste

RxCUI
1921772
RxNorm name
calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste
Display name
Calamine/Menthol/Petrolatum/Zinc oxide (Paste)
Full name
calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste
Term type
SCD
Status
Active
Strength
3.5-0.2-69-16.5%
Dose form
Paste
Route
Paste
Updated
2026-10-27 19:32:21

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
062017
Active start
062017
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
calamine0.035 MG / 1 MGcalaminecalamine
zinc oxide0.165 MG / 1 MGzinc oxidezinc oxide
menthol0.002 MG / 1 MGmentholmenthol
petrolatum0.69 MG / 1 MGpetrolatumpetrolatum

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Paste402496

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
calamine106212
zinc oxide11423
menthol6750
petrolatum8091

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRcalamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste1NAMES
RxNorm Namecalamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID1295cfcc-5b61-481b-964b-f53ffd0cb58e1CODES
RxCUI19217721CODES
MMSL_CODEBD292161CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
53329-165-0253329-165REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxideMedline Industries, LPM015
53329-165-4453329-165REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxideMedline Industries, LPM015

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01553329-165REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxideOTC MONOGRAPH DRUGMedline Industries, LP

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
53329016502rxnav_ndcsyes
53329016544rxnav_ndcsyes
53329016596rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
ndc (package): 53329-165-44
ndc (package): 53329-165-02
ndc (product): 53329-165
ndc11 (package): 53329016502
ndc11 (package): 53329016596
ndc11 (package): 53329016544
rxcui: 1921772

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1295cfcc-5b61-481b-964b-f53ffd0cb58ecalamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste [PSN] · calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste [SCD] · Calamine 0.035 MG/MG / Menthol 0.002 MG/MG / Petrolatum 0.69 MG/MG / ZNO 0.165 MG/MG Paste [SY] · calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste [SY]49165 REMEDY Calazime Skin Protectant20250129

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1295cfcc-5b61-481b-964b-f53ffd0cb58e165 REMEDY Calazime Skin ProtectantMedline Industries, LP20251030
1295cfcc-5b61-481b-964b-f53ffd0cb58e165 REMEDY Calazime Skin ProtectantMedline Industries, LP20250129

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
MEDRTD008610MentholCHEMhas_ingredientmenthol
MEDRTD010577PetrolatumCHEMhas_ingredientpetrolatum
MEDRTD015034Zinc OxideCHEMhas_ingredientzinc oxide
MEDRTD019080Cafe-au-Lait SpotsDISEASEmay_preventzinc oxide
MEDRTD003876Dermatitis, AtopicDISEASEmay_treatzinc oxide
MEDRTD003877Dermatitis, ContactDISEASEmay_preventcalamine
MEDRTD003963Diaper RashDISEASEmay_treatzinc oxide
MEDRTD004342Drug HypersensitivityDISEASEci_withcalamine
MEDRTD004342Drug HypersensitivityDISEASEci_withmenthol
MEDRTD004342Drug HypersensitivityDISEASEci_withzinc oxide
MEDRTD004485EczemaDISEASEmay_treatzinc oxide
MEDRTD010146PainDISEASEmay_treatmenthol
MEDRTD010939Plant PoisoningDISEASEmay_preventcalamine
MEDRTD012871Skin DiseasesDISEASEmay_treatmenthol
MEDRTD012878Skin NeoplasmsDISEASEmay_preventzinc oxide
MEDRTD013471SunburnDISEASEmay_preventzinc oxide
MEDRTD014947Wounds and InjuriesDISEASEmay_treatzinc oxide
MEDRTN0000000069Calcium Channel AntagonistsMOAhas_moamenthol
MEDRTN0000000065Physiochemical ActivityMOAhas_moazinc oxide
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moacalamine
MEDRTN0000008301Astringent ActivityPEhas_pecalamine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pementhol
MEDRTN0000010282Skin Barrier ActivityPEhas_pecalamine
MEDRTN0000009881Sunscreening ActivityPEhas_pezinc oxide

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.035 MG/MG / 0.002 MG/MG / 0.69 MG/MG / 0.165 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4036551
NAMESPrescribable Synonymcalamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary