Dawnmist Petroleum

Product NDC
65517-2020
11-digit product format
655172020
Labeler code
65517
Product ID
65517-2020_ea23b188-d02f-1e4f-e053-2a95a90a5d5c
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Dukal Corp
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-10-24
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
100 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65517-2020DDiscontinued by firm2026-10-16
excluded packagepackage65517-202065517-2020-1DDiscontinued by firm2026-10-16
excluded packagepackage65517-202065517-2020-2DDiscontinued by firm2026-10-16
excluded packagepackage65517-202065517-2020-3DDiscontinued by firm2026-10-16
excluded packagepackage65517-202065517-2020-4DDiscontinued by firm2026-10-16
excluded packagepackage65517-202065517-2020-5DDiscontinued by firm2026-10-16

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0565517-2020-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0565517-2020-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0565517-2020-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2665517-2020-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2665517-2020-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2665517-2020-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3165517-2020-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3165517-2020-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3165517-2020-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2865517-2020-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2865517-2020-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2865517-2020-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2165517-2020-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2165517-2020-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2165517-2020-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1065517-2020-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1065517-2020-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1065517-2020-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3165517-2020-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3165517-2020-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3165517-2020-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2065517-2020-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2065517-2020-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2065517-2020-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1065517-2020-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1065517-2020-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1065517-2020-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0865517-2020-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0865517-2020-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0865517-2020-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0365517-2020-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0365517-2020-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0365517-2020-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0965517-2020-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0965517-2020-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0965517-2020-3557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2020-1Dawnmist Petroleum56 g in 1 TUBEJELLY567
65517-2020-2Dawnmist Petroleum198 g in 1 TUBEJELLY1987
65517-2020-3Dawnmist Petroleum5 g in 1 PACKETJELLY57
65517-2020-4Dawnmist Petroleum368 g in 1 JARJELLY3687
65517-2020-5Dawnmist Petroleum28 g in 1 TUBEJELLY287

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9UDAWNMIST PETROLEUM (PETROLATUM) JELLY [DUKAL CORP]1
PetrolatumACTIVE MOIETY4T6H12BN9UDAWNMIST PETROLEUM (PETROLATUM) JELLY [DUKAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2020DAWNMIST PETROLEUM (PETROLATUM) JELLY [DUKAL LLC]7Legacy NDC, 5 package rows20240724_9eb0498a-7601-4ea8-993d-c0f883457ee9.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 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b2023-12-20WarningsExact identifier
application number: M016
Best Choice Medicated CalamineZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO.5d6c668a-80b4-de18-e053-2991aa0a38fb2023-12-20WarningsExact identifier
application number: M016
Premiere Value CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Consortium5c8bde5a-591d-085f-e053-2991aa0a56af2023-12-20WarningsExact identifier
application number: M016
Best Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEValu Merchandisers, CO5d6c51b8-47f8-c38b-e053-2991aa0a0f232023-12-20WarningsExact identifier
application number: M016
Health Care CalamineCALAMINE 8% AND ZINC OXIDE 8%Great Lakes Wholesale, Marketing and Sales Inc5d8f02fb-0794-8ec2-e053-2991aa0aac632023-12-20WarningsExact identifier
application number: M016
Harris Teetter CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEHarris Tetter, LLC.5c7a7418-c973-2869-e053-2991aa0ab4f52023-12-20WarningsExact identifier
application number: M016
Harris Teeter CalamineZINC OXIDEHarris Teeter, LLC.86021cc5-fea7-4363-8fb2-2b0484437fe82023-12-20WarningsExact identifier
application number: M016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN9eb0498a-7601-4ea8-993d-c0f883457ee97
204754petrolatum 1 MG/MG Topical OintmentSCD9eb0498a-7601-4ea8-993d-c0f883457ee97
204754petrolatum 100 % Topical JellySY9eb0498a-7601-4ea8-993d-c0f883457ee97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-2020-16551720200156 g in 1 TUBE (65517-2020-1) 56 g2014-10-240000-00-00NoNoCurrent
65517-2020-265517202002198 g in 1 TUBE (65517-2020-2) 198 g2014-10-240000-00-00NoNoCurrent
65517-2020-3655172020035 g in 1 PACKET (65517-2020-3) 5 g2014-10-240000-00-00NoNoCurrent
65517-2020-465517202004368 g in 1 JAR (65517-2020-4) 368 g2014-10-240000-00-00NoNoCurrent
65517-2020-56551720200528 g in 1 TUBE (65517-2020-5) 28 g2021-06-160000-00-00NoNoCurrent