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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact 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