FDA.reportPublic FDA data

Vitamin A D

Product NDC
68786-213
11-digit product format
687860213
Labeler code
68786
Product ID
68786-213_4c9d7f9a-6e37-d92e-e063-6394a90aeac0
Type
HUMAN OTC DRUG
Nonproprietary name
WHITE PETROLATUM
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-14
Substance
PETROLATUM
Active strength
.93 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Vitamin A D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM.93 g/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
1440181Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
503c4ab9-1f60-48e2-af47-7ef996466a5bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68786-213-01Vitamin A D6 in 1 CASEOINTMENT69
68786-213-01Vitamin A D144 in 1 BOXOINTMENT1449
68786-213-02Vitamin A D18 in 1 CASEOINTMENT189
68786-213-02Vitamin A D4 in 1 BOXOINTMENT49
68786-213-03Vitamin A D12 in 1 BOXOINTMENT129
68786-213-03Vitamin A D6 in 1 CASEOINTMENT69
68786-213-04Vitamin A D56 in 1 CASEOINTMENT569
68786-213-04Vitamin A D1 in 1 BOXOINTMENT19
68786-213-05Vitamin A D144 in 1 BOXOINTMENT1449
68786-213-05Vitamin A D6 in 1 CASEOINTMENT69

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-213VITAMIN A D (WHITE PETROLATUM) OINTMENT [SION BIOTEXT MEDICAL LTD.]7Current NDC, Legacy NDC, 10 package rows20240125_503c4ab9-1f60-48e2-af47-7ef996466a5b.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 14 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic SpearmintSKIN PROTECTANT LIP BALMSuave Brands Co., LLC4523af69-1a0d-6d18-e063-6394a90ad9d12026-03-30WarningsExact identifier
application number: M016
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1440181petrolatum 93 % Topical OintmentPSN503c4ab9-1f60-48e2-af47-7ef996466a5b9
1440181petrolatum 0.93 MG/MG Topical OintmentSCD503c4ab9-1f60-48e2-af47-7ef996466a5b9
1440181petrolatum 93 % Topical OintmentSY503c4ab9-1f60-48e2-af47-7ef996466a5b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68786-213-01687860213016 BOX in 1 CASE (68786-213-01) / 144 PACKET in 1 BOX / 5 g in 1 PACKET6 box2017-02-140000-00-00NoNoCurrent
68786-213-026878602130218 BOX in 1 CASE (68786-213-02) / 4 PACKET in 1 BOX / 113 g in 1 PACKET18 box2017-02-140000-00-00NoNoCurrent
68786-213-03687860213036 BOX in 1 CASE (68786-213-03) / 12 PACKET in 1 BOX / 113 g in 1 PACKET6 box2019-01-310000-00-00NoNoCurrent
68786-213-046878602130456 BOX in 1 CASE (68786-213-04) / 1 TUBE in 1 BOX / 113 g in 1 TUBE56 box2017-02-140000-00-00NoNoCurrent
68786-213-05687860213056 BOX in 1 CASE (68786-213-05) / 144 PACKET in 1 BOX / 5 g in 1 PACKET6 box2017-02-140000-00-00NoNoCurrent