FDA.reportPublic FDA data

Vitamin A D

Product NDC
68786-213
Requested package NDC
68786-213-01
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 43 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
application number: M016
5% Signature Numb cream5% SIGNATUREShengnan (Guangzhou) Cosmetics Co., LTD2f80abc0-49d8-968d-e063-6294a90a555b2025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19b3056-063c-63ec-e053-2995a90a46142025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint TwistCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2770424d-7414-66d4-e063-6394a90ad4b12025-03-04WarningsExact identifier
application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
application number: M016
5% Dr.care Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f905d76-ef9c-c844-e063-6394a90a4dc92025-03-04WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
application number: M016
Perineal Cooling LinersWITCH HAZELCVS Pharmacy88f44650-8fb7-4eb2-901d-30eb8415dc2b2025-02-25WarningsExact identifier
application number: M016
5% Signature Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f043d3c-d8db-414e-e063-6394a90a13de2025-02-25WarningsExact 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