FDA.reportPublic FDA data

Secura Protective

Product NDC
69740-312
11-digit product format
697400312
Labeler code
69740
Product ID
69740-312_1ab291a4-b8b3-e4f6-e063-6394a90a3d30
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Smith & Nephew Medical Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-08-01
Substance
ZINC OXIDE
Active strength
100 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 2 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
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69740-312IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69740-31269740-312-00IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Secura Protective
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
248279Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b077aa64-49a3-42ee-abb3-88f833635b93Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-312-002024-03-13C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream
69740-312-002024-01-30C16284748780-11030e365-4455-111a-e063-dadaa90a10e2Secura Protective Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-312-00Secura Protective78 g in 1 TUBECREAM78153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69740-312-00GM - Gram69740-312ac89215f-6eaa-4226-8883-098b7a86f08812022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ALLANTOININACTIVE INGREDIENT344S277G0ZSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ALOEINACTIVE INGREDIENTV5VD430YW9SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ALOE VERA FLOWERINACTIVE INGREDIENT575DY8C1ERSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
CLOVE OILINACTIVE INGREDIENT578389D6D0SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
POLYOXYL 40 CASTOR OILINACTIVE INGREDIENT4ERD2076EFSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RSECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-312SECURA PROTECTIVE (ZINC OXIDE) CREAM [SMITH & NEPHEW MEDICAL LTD]153Current NDC, Legacy NDC, 1 package rows20240614_b077aa64-49a3-42ee-abb3-88f833635b93.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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005
Fungicure Anti-Fungal LiquidTOLNAFTATEKobayashi Healthcare International, Inc.b18ee199-0659-733c-e053-2a95a90ab6b52026-04-01WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYCVS Pharmacy96cc594d-85c8-4f62-bc0a-3176c8739f212026-04-01WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYCVS Pharmacya7b6bd7c-23db-43e1-92f7-e27f5f4801de2026-04-01WarningsExact identifier
application number: M005
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
application number: M005
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
application number: M005
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248279zinc oxide 10 % Topical CreamPSNb077aa64-49a3-42ee-abb3-88f833635b93153
248279zinc oxide 100 MG/ML Topical CreamSCDb077aa64-49a3-42ee-abb3-88f833635b93153
248279zinc oxide 10 % Topical CreamSYb077aa64-49a3-42ee-abb3-88f833635b93153
248279ZNO 100 MG/ML Topical CreamSYb077aa64-49a3-42ee-abb3-88f833635b93153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69740-312-006974003120078 g in 1 TUBE (69740-312-00) 78 g2003-08-010000-00-00NoNoCurrent