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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81995-056-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	81995-056-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81995-056-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	81995-056-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81995-056-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	81995-056-01	`0efc9e666f02…`	`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
Ingredient	Strength
ALLANTOIN	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
344S277G0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f40a9a34-1827-7171-e053-2a95a90acf31	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
81995-056-01	2025-02-05	First honey Burn Salve
81995-056-02	2025-02-05	First honey Burn Salve
81995-056-01	2025-01-30	First honey Burn Salve
81995-056-02	2025-01-30	First honey Burn Salve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81995-056-01	First honey Burn Salve	1 in 1 CARTON	CREAM	1	4
81995-056-01	First honey Burn Salve	100 mL in 1 TUBE	CREAM	100	4
81995-056-02	First honey Burn Salve	1 in 1 CARTON	CREAM	1	4
81995-056-02	First honey Burn Salve	5 mL in 1 POUCH	CREAM	5	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81995-056	FIRST HONEY BURN SALVE (ALLANTOIN) CREAM [FIRST HONEY, LLC]	4	Current NDC, 4 package rows	20250206_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 64 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premier Value Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Consortium	5c89e3ac-ca4d-ec3a-e053-2a91aa0a1c0b	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Medicated Calamine	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO.	5d6c668a-80b4-de18-e053-2991aa0a38fb	2023-12-20	Warnings	Exact identifier application number: M016
Premiere Value Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Consortium	5c8bde5a-591d-085f-e053-2991aa0a56af	2023-12-20	Warnings	Exact identifier application number: M016
Best Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Valu Merchandisers, CO	5d6c51b8-47f8-c38b-e053-2991aa0a0f23	2023-12-20	Warnings	Exact identifier application number: M016
Health Care Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Great Lakes Wholesale, Marketing and Sales Inc	5d8f02fb-0794-8ec2-e053-2991aa0aac63	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teetter Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Harris Tetter, LLC.	5c7a7418-c973-2869-e053-2991aa0ab4f5	2023-12-20	Warnings	Exact identifier application number: M016
Harris Teeter Calamine	ZINC OXIDE	Harris Teeter, LLC.	86021cc5-fea7-4363-8fb2-2b0484437fe8	2023-12-20	Warnings	Exact identifier application number: M016
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	8e68efc4-4c95-41c0-9fed-32297b1b2edc	2023-12-19	Warnings	Exact identifier application number: M016
Calm and Heal Melting Balm	ALLANTOIN	The Honest Company, Inc.	b08a1bd6-986d-9520-e053-2995a90a865e	2023-12-19	Warnings	Exact identifier application number: M016
TopCare Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION	TOPCO ASSOCIATES LLC	8dced3ea-147b-3d46-e053-2a95a90aa1c0	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d576794-88d1-484a-e053-2991aa0aa479	2023-12-18	Warnings	Exact identifier application number: M016
Publix Calamine Medicated	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	TOPCO ASSOCIATES LLC	8dce8817-b905-4064-e053-2995a90a071e	2023-12-18	Warnings	Exact identifier application number: M016
Assured Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Greenbriar International	9d378cc5-9af0-1389-e053-2995a90a0b96	2023-12-18	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
241509	allantoin 0.5 % Topical Cream	PSN	f40a9a34-1827-7171-e053-2a95a90acf31	4
241509	allantoin 5 MG/ML Topical Cream	SCD	f40a9a34-1827-7171-e053-2a95a90acf31	4
241509	allantoin 0.5 % Topical Cream	SY	f40a9a34-1827-7171-e053-2a95a90acf31	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81995-056-01	81995005601	1 TUBE in 1 CARTON (81995-056-01) / 100 mL in 1 TUBE	1 tube	2022-05-10	No	No	Current
81995-056-02	81995005602	1 POUCH in 1 CARTON (81995-056-02) / 5 mL in 1 POUCH	1 pouch	2023-06-01	No	No	Current