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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD Laser BalmPETROLATUM SKIN PROTECTANTCP Skin Health Group, Inc1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb2023-11-09WarningsExact identifier
application number: M016
DiaperDerm Diaper RashZINC OXIDEDiaperderm Inc4e1fce3e-c2b7-42da-9953-1dbb13e2467c2023-11-06WarningsExact identifier
application number: M016
Doctors Diaper Rash CreamZINC OXIDEDOCTOR'S DIAPER RASH CREAM, INC0988ccb1-7881-4d97-bcbf-d0cf4316e4be2023-11-06WarningsExact identifier
application number: M016
DERMOIA Manuka Honey Eczema CreamOATMEALTREASUREWISE LLCa48e52a3-b681-4489-a1fd-6b09d8bc9c552023-11-06WarningsExact identifier
application number: M016
GL HEALTH Barrier Skin ProtectantZINC OXIDEGL HEALTH, INC.76cfa330-fea9-48d4-b187-469154765d392023-11-06WarningsExact identifier
application number: M016
Skin-lubePETROLATUM, DIMETHICONEThe Hygenic Company, LLC.d1005dec-04f6-3f88-e053-2a95a90ad9cb2023-11-05WarningsExact identifier
application number: M016
Dr. Sheffield Anti Itch CreamANTI ITCH CREAMSheffield Pharmaceuticals LLC77f0593e-f694-4c02-9fd9-ad56ff2a920c2023-10-30WarningsExact identifier
application number: M016
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
application number: M016
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
application number: M016
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
application number: M016
Theriac Advanced HealingLANOLINSheffield Pharmaceuticals LLCc780cd27-dc9e-45f3-97f0-e59b1b6b955a2023-10-24WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.d66e369e-9b19-b084-e053-2995a90aa2592023-10-23WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact 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