FDA.reportPublic FDA data

Calprotect

Product NDC
69618-067
11-digit product format
696180067
Labeler code
69618
Product ID
69618-067_4b32706a-c97a-589c-e063-6294a90abc11
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Reliable 1 Laboratories LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
ZINC OXIDE; MENTHOL
Active strength
20.6; .44 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct69618-067UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69618-06769618-067-82UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69618-06769618-067-71UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Calprotect
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20.6 g/100g
MENTHOL.44 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2123045Internal RxNorm lookup
2702497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09fb2810-0cc1-b2e2-e063-6294a90a4576Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-067-71Calprotect71 g in 1 JAROINTMENT715
69618-067-82Calprotect113 g in 1 TUBEOINTMENT1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-067-71GM - Gram69618-0674d28b714-56c8-4898-a629-9c8e2cde284312023-12-05
69618-067-82GM - Gram69618-0672549dd69-0e5c-435a-aa71-3b84f4ead93512023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-067CALPROTECT (MENTHOL, ZINC OXIDE) OINTMENT [RELIABLE 1 LABORATORIES LLC]4Current NDC, 2 package rows20250121_09fb2810-0cc1-b2e2-e063-6294a90a4576.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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
application number: M015
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsExact identifier
application number: M015
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
application number: M015
topcare hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLTopco Associates LLC81a3546b-5099-4b9a-b774-b3e79316b2672025-12-13WarningsExact identifier
application number: M015
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
application number: M015
LMX5LIDOCAINEFerndale Laboratories, Inc.34f8ed6b-4a52-4a99-9c1b-254196dc29b02025-12-10WarningsExact identifier
application number: M015
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
application number: M015
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
application number: M015
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
application number: M015
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
application number: M015
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015
Hazel Perineal Healing FoamWITCH HAZELJiangsu Senwo Medical Technology Co., Ltd.314b75cb-affe-a248-e063-6294a90a47b72025-11-07WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702497CalProtect 0.44 % / zinc oxide 20.6 % Topical OintmentPSN09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentPSN09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calprotect]SBD09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497Calprotect (menthol 0.44 % / zinc oxide 20.6 % ) Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765
2702497menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calprotect]SY09fb2810-0cc1-b2e2-e063-6294a90a45765
2123045menthol 0.44 % / zinc oxide 20.6 % Topical OintmentSY09fb2810-0cc1-b2e2-e063-6294a90a45765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69618-067-716961800677171 g in 1 JAR (69618-067-71) 71 g2021-01-01NoNoCurrent
69618-067-8269618006782113 g in 1 TUBE (69618-067-82) 113 g2021-01-01NoNoCurrent