FDA.reportPublic FDA data

Jell Pharmaceuticals Vitamin A D

Product NDC
30400-214
11-digit product format
304000214
Labeler code
30400
Product ID
30400-214_2974f712-dadd-bbff-e063-6294a90a8d84
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt. Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-24
Substance
PETROLATUM
Active strength
.76 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage30400-214-03
excluded packagepackage30400-214-04
excluded packagepackage30400-214-02
excluded packagepackage30400-214-01

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
Jell Pharmaceuticals Vitamin A D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM.76 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
1049072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ab8ba54-3679-4fd0-a876-cb89aace96caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
30400-214-012020-07-28Vitamin A D
30400-214-022020-07-28Vitamin A D
30400-214-032020-07-28Vitamin A D
30400-214-042020-07-28Vitamin A D
30400-214-012020-01-31Vitamin A D
30400-214-022020-01-31Vitamin A D
30400-214-032020-01-31Vitamin A D
30400-214-042020-01-31Vitamin A D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-214-01Jell Pharmaceuticals Vitamin A D113.4 g in 1 TUBEOINTMENT113.43
30400-214-02Jell Pharmaceuticals Vitamin A D425.25 g in 1 JAROINTMENT425.253
30400-214-03Jell Pharmaceuticals Vitamin A D28.35 g in 1 TUBEOINTMENT28.353
30400-214-04Jell Pharmaceuticals Vitamin A D56.7 g in 1 TUBEOINTMENT56.73

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UJELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UJELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41JELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HJELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPJELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCJELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-214JELL PHARMACEUTICALS VITAMIN A D (PETROLATUM) OINTMENT [JELL PHARMACEUTICALS PVT. LTD.]3Current NDC, Legacy NDC, 4 package rows20241219_6ab8ba54-3679-4fd0-a876-cb89aace96ca.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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049072petrolatum 76 % Topical OintmentPSN6ab8ba54-3679-4fd0-a876-cb89aace96ca3
1049072petrolatum 0.76 MG/MG Topical OintmentSCD6ab8ba54-3679-4fd0-a876-cb89aace96ca3
1049072petrolatum 76 % Topical OintmentSY6ab8ba54-3679-4fd0-a876-cb89aace96ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-214-0130400021401113.4 g in 1 TUBE (30400-214-01) 113.4 g2020-07-010000-00-00NoNoCurrent
30400-214-0230400021402425.25 g in 1 JAR (30400-214-02) 425.25 g2020-07-010000-00-00NoNoCurrent
30400-214-033040002140328.35 g in 1 TUBE (30400-214-03) 28.35 g2020-07-010000-00-00NoNoCurrent
30400-214-043040002140456.7 g in 1 TUBE (30400-214-04) 56.7 g2020-07-010000-00-00NoNoCurrent