FDA.reportPublic FDA data

First honey Burn Salve

Product NDC
81995-056
11-digit product format
819950056
Labeler code
81995
Product ID
81995-056_2d5e186d-35d6-81b9-e063-6294a90a9daa
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN
Dosage form
CREAM
Route
TOPICAL
Labeler
First Honey, LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
ALLANTOIN
Active strength
5 mg/mL
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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage81995-056-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage81995-056-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81995-056-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage81995-056-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81995-056-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81995-056-010efc9e666f02…f202fb6c5f17…

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
First honey Burn Salve
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
241509Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f40a9a34-1827-7171-e053-2a95a90acf31Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
81995-056-012025-02-05First honey Burn Salve
81995-056-022025-02-05First honey Burn Salve
81995-056-012025-01-30First honey Burn Salve
81995-056-022025-01-30First honey Burn Salve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81995-056-01First honey Burn Salve1 in 1 CARTONCREAM14
81995-056-01First honey Burn Salve100 mL in 1 TUBECREAM1004
81995-056-02First honey Burn Salve1 in 1 CARTONCREAM14
81995-056-02First honey Burn Salve5 mL in 1 POUCHCREAM54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81995-056FIRST HONEY BURN SALVE (ALLANTOIN) CREAM [FIRST HONEY, LLC]4Current NDC, 4 package rows20250206_f40a9a34-1827-7171-e053-2a95a90acf31.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 35 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.59d90652-a471-4f77-a3d5-88aad9dc9e132025-10-30WarningsExact identifier
application number: M016
CVS Cools Itch FastHYDROCORTISONECVS Pharmacy, Inc.8a4544df-bbba-47d2-ada0-352757abc91f2025-10-29WarningsExact identifier
application number: M016
Winco Maximum Strength HydrocortisoneHYDROCORTISONEWINCO FOODS, LLCb1812ea3-78cc-607a-e053-2a95a90a0a102025-10-29WarningsExact identifier
application number: M016
Good Neighbor Pharmacy Skin ProtectantZINC OXIDEAMERISOURCE BERGENc28e63f1-34be-9206-e053-2995a90accf62025-10-29WarningsExact identifier
application number: M016
Remedy NutrashieldDIMETHICONEMedline Industries, LPed8a08a7-594c-46e2-b70f-b75b2960141f2025-10-28WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)MY IMPORTS USA LLC421da126-a1c4-54d7-e063-6394a90ac4012025-10-27WarningsExact identifier
application number: M016
GeriGardZINC OXIDEGeri-Gentle Corporation05b67830-adc8-46b1-b0a0-a6cd2875e80c2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Butt BarrierDIMETHICONEC.B. Fleet Company, Inc.06a5af4d-40dd-42a4-8368-4d6a772d1b3a2025-10-27WarningsExact identifier
application number: M016
Boudreauxs Baby Shower BundleZINC OXIDEC.B. Fleet Company, Inc.a289ed3c-3c7a-4eda-bf5e-139203d2e17e2025-10-27WarningsExact identifier
application number: M016
WinCo Original Strength Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE, AND ZINC ACETATEWinCo Foods, LLCae74e163-ba1a-4d1e-aaeb-9976bd2026742025-10-24WarningsExact identifier
application number: M016
Maximum Strength Moisture BarrierPETROLATUM AND ZINC OXIDEDerma Sciences Canada Inc.41ee91c0-d196-cc0f-e063-6394a90a7b972025-10-24WarningsExact identifier
application number: M016
TenderphorSKIN PROTECTANTGERI-GENTLE CORPORATIONe6763da3-cbd1-7a86-e053-2995a90a26c12025-10-23WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.262278f6-7e4c-44ee-b40d-39662a239d732025-10-23WarningsExact identifier
application number: M016
American Red Cross Anti-ItchHYDROCORTISONE 1.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b8cb00-a04e-52f0-e063-6294a90aabf72025-10-22WarningsExact identifier
application number: M016
WinCo Foods Hydrocortisone Cream Intensive HealingHYDROCORTISONEWINCO FOODS, LLCac4e0e24-9295-b83b-e053-2995a90a996f2025-10-22WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241509allantoin 0.5 % Topical CreamPSNf40a9a34-1827-7171-e053-2a95a90acf314
241509allantoin 5 MG/ML Topical CreamSCDf40a9a34-1827-7171-e053-2a95a90acf314
241509allantoin 0.5 % Topical CreamSYf40a9a34-1827-7171-e053-2a95a90acf314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81995-056-01819950056011 TUBE in 1 CARTON (81995-056-01) / 100 mL in 1 TUBE1 tube2022-05-10NoNoCurrent
81995-056-02819950056021 POUCH in 1 CARTON (81995-056-02) / 5 mL in 1 POUCH1 pouch2023-06-01NoNoCurrent