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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
First honey Burn Salve
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z
Rxcui241509

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81995-056-012025-02-05C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-022025-02-05C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-012025-01-30C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst honey Burn Salve
81995-056-022025-01-30C16284748780-12cef2736-9130-d83d-e063-dadaa90ab31fFirst 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

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 tube2022-05-10NoNoHistorical
81995-056-02819950056021 POUCH in 1 CARTON (81995-056-02) / 5 mL in 1 POUCH1 pouch2023-06-01NoNoHistorical