Honest Eczema Balm

Product NDC: 69366-503
11-digit product format: 693660503
Labeler code: 69366
Product ID: 69366-503_187119a5-7b90-fa56-e063-6294a90a132f
Type: HUMAN OTC DRUG
Nonproprietary name: Colloidal Oatmeal
Dosage form: OINTMENT
Route: TOPICAL
Labeler: The Honest Company, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-01
Substance: OATMEAL
Active strength: 1 g/100g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69366-503	69366-503-20	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Honest Eczema Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OATMEAL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8PI54V663Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1545142	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
35b8bc5c-420e-4d31-9659-f36cabbd897a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69366-503-20	Honest Eczema Balm	85 g in 1 JAR	OINTMENT	85		5
69366-503-20	Honest Eczema Balm	1 in 1 CARTON	OINTMENT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69366-503	HONEST ECZEMA BALM (COLLOIDAL OATMEAL) OINTMENT [THE HONEST COMPANY, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20240516_35b8bc5c-420e-4d31-9659-f36cabbd897a.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, Matched term table
UNII	Preferred term	Matched term
8PI54V663Y	OATMEAL	OATMEAL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1545142	colloidal oatmeal 1 % Topical Ointment	PSN	35b8bc5c-420e-4d31-9659-f36cabbd897a	5
1545142	colloidal oatmeal 0.01 MG/MG Topical Ointment	SCD	35b8bc5c-420e-4d31-9659-f36cabbd897a	5
1545142	colloidal oatmeal 1 % Topical Ointment	SY	35b8bc5c-420e-4d31-9659-f36cabbd897a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69366-503-20	69366050320	1 JAR in 1 CARTON (69366-503-20) > 85 g in 1 JAR	1 jar	2019-07-01	0000-00-00	No	No	Current