FDA.reportPublic FDA data

Secura Protective

Product NDC
69740-316
11-digit product format
697400316
Labeler code
69740
Product ID
69740-316_1e9fedee-d49d-2539-e063-6394a90a05bd
Type
HUMAN OTC DRUG
Nonproprietary name
petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Smith & Nephew Medical Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-08-01
Substance
PETROLATUM
Active strength
988.49 mg/g
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 productproduct69740-316IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69740-31669740-316-00IInactivated 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
PETROLATUM988.49 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581802Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20906566-fbf2-46d9-a5d8-c7f7356d1080Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69740-316-002024-03-27C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment
69740-316-002024-01-30C16284748780-11030e365-0153-111a-e063-dadaa90a10e2Secura Protective Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69740-316-00Secura Protective159 g in 1 TUBEOINTMENT15911

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9USECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
PETROLATUMACTIVE MOIETY4T6H12BN9USECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
CLOVE OILINACTIVE INGREDIENT578389D6D0SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
CORN OILINACTIVE INGREDIENT8470G57WFMSECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
D&C GREEN NO. 6INACTIVE INGREDIENT4QP5U84YF7SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69740-316SECURA PROTECTIVE (PETROLATUM) OINTMENT [SMITH & NEPHEW MEDICAL LTD]11Current NDC, Legacy NDC, 1 package rows20240809_20906566-fbf2-46d9-a5d8-c7f7356d1080.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 13 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colloidal oatmealCOLLOIDAL OATMEALCVS Pharmacy, Inc.4a43b1a2-2156-e490-e063-6294a90a6f842026-04-07Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZEL SPRAYCVS Pharmacy53db78a8-eb2d-431b-84c1-73e99bb9d3d12026-04-06WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
application number: M016
Stabilizing Repair SerumOATMEALDermalogica, LLC.86b7b230-5424-46d3-8058-656f5172fc702026-04-02WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDESTRATEGIC SOURCING SERVICES4e6a7bdf-4ef1-65e2-e063-6394a90ae1242026-04-01WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Rescue Relief Treatment Gel CreamCOLLOIDAL OATMEALKenvue Brands LLC4e4e1797-26e6-a67b-e063-6294a90af4382026-03-31WarningsExact identifier
application number: M016
Target Advanced Scar GelADVANCED SCAR GELTarget Corporation86c215fe-aad4-45d1-bdb7-cde00a115c5c2026-03-31WarningsExact identifier
application number: M016
Zinc oxide, DimethiconeZINC OXIDE, DIMETHICONEWalmart Inc.4cbf9492-33cd-e6d4-e063-6294a90ab0012026-03-31Warnings, Adverse reactionsExact identifier
application number: M016
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
application number: M016
3M Cavilon Durable BarrierDIMETHICONESolventum US LLCf3f8be33-4ad2-4f5f-ac94-ddfbe0280b832026-03-31WarningsExact identifier
application number: M016
XIMONTH Foot SanitizerGLYCERINShantou Ximonth Biotechnology Co., Ltd.4e38d24d-3745-c121-e063-6394a90abbb52026-03-30WarningsExact identifier
application number: M016
DynashieldZINC OXIDEDynarex Corporation59fd865c-b81d-43ad-8fa0-c37ca05577692026-03-30WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALPort Jervis Laboratories, Inc4e43b65c-d5bb-f228-e063-6294a90ad08d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4275956d-275a-4e31-e063-6394a90a78d32026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42762471-e5cd-505e-e063-6294a90afb7d2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Variety Cherry-Strawberry-SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC450e46d2-de86-e5fa-e063-6294a90ac6ff2026-03-30WarningsExact identifier
application number: M016
ChapStick Classic OriginalSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512220a-9fc2-8816-e063-6394a90a9d152026-03-30WarningsExact identifier
application number: M016
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC45136b7e-136b-0283-e063-6394a90a599a2026-03-30WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581802petrolatum 98.8 % Topical OintmentPSN20906566-fbf2-46d9-a5d8-c7f7356d108011
581802petrolatum 0.988 MG/MG Topical OintmentSCD20906566-fbf2-46d9-a5d8-c7f7356d108011
581802petrolatum 98.8 % Topical OintmentSY20906566-fbf2-46d9-a5d8-c7f7356d108011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69740-316-0069740031600159 g in 1 TUBE (69740-316-00) 159 g2024-05-240000-00-00NoNoCurrent