Domeboro

Product NDC: 16864-240
11-digit product format: 168640240
Labeler code: 16864
Product ID: 16864-240_29165706-4e15-97ab-e063-6294a90a6613
Type: HUMAN OTC DRUG
Nonproprietary name: Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate
Dosage form: POWDER, FOR SOLUTION
Route: TOPICAL
Labeler: Advantice Health, LLC.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-06-26
Substance: ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE
Active strength: 1347; 952 mg/1; mg/1
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16864-240	16864-240-10	D	Discontinued by firm		2026-10-21
excluded package	package	16864-240	16864-240-14	D	Discontinued by firm		2026-10-21

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	16864-240-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	16864-240-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	16864-240-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	16864-240-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	16864-240-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	16864-240-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	16864-240-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	16864-240-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	16864-240-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	16864-240-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	16864-240-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	16864-240-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	16864-240-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	16864-240-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	16864-240-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	16864-240-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	16864-240-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	16864-240-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	16864-240-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	16864-240-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	16864-240-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	16864-240-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	16864-240-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	16864-240-10	`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: Domeboro
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALUMINUM SULFATE TETRADECAHYDRATE	1347 mg/1
CALCIUM ACETATE MONOHYDRATE	952 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E3UT66504P	Internal UNII lookup
7ZA48GIM5H	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1250234	Internal RxNorm lookup
1293268	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
28c39200-2f7c-954b-3ce7-7349b2738812	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16864-240-01	Domeboro	12 in 1 BOX	POWDER, FOR SOLUTION	12	10
16864-240-10	Domeboro	100 in 1 BOX	POWDER, FOR SOLUTION	100	10
16864-240-14	Domeboro	14 in 1 BOX	POWDER, FOR SOLUTION	14	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16864-240-01	EA - Each	16864-240	200554ae-f5db-4804-9910-4246fe5f6619	1	2020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM SULFATE TETRADECAHYDRATE	ACTIVE INGREDIENT	E3UT66504P	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]	2
CALCIUM ACETATE MONOHYDRATE	ACTIVE INGREDIENT	7ZA48GIM5H	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]	2
ALUMINUM CATION	ACTIVE MOIETY	3XHB1D032B	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]	2
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]	2
Icodextrin	INACTIVE INGREDIENT	2NX48Z0A9G	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16864-240	DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [ADVANTICE HEALTH, LLC.]	10	Current NDC, Legacy NDC, 3 package rows	20241215_28c39200-2f7c-954b-3ce7-7349b2738812.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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A and D	VITAMIN A AND D	MIDWOOD BRANDS, LLC	1d0ebe9a-cbc5-1765-e063-6294a90aa476	2024-07-18	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MIDWOOD BRANDS, LLC.	1d0eb8be-13b7-c466-e063-6294a90a93b9	2024-07-11	Warnings	Exact identifier application number: M016
Ivarest	ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE	Blistex Inc	6f68cbbb-6269-4bb3-8cc9-50b146703b42	2024-07-09	Warnings	Exact identifier application number: M016
Best Choice Diaper Rash	ZINC OXIDE	Trifecta Pharmaceuticals USA LLC	1be37841-e0a8-a0de-e063-6294a90a9eb1	2024-06-27	Warnings	Exact identifier application number: M016
Gas Relief Ultra Strength	SIMETHICONE	Walgreens	00a9164a-1817-4130-9c7f-9f5833c9690f	2024-06-26	Warnings	Exact identifier application number: M016
Astonea Skin Protectant	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	e3c7a515-3e77-da85-e053-2995a90a3ee1	2024-06-25	Warnings	Exact identifier application number: M016
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier application number: M016
ZOEY NATURALS DIAPER Cream	ZINC OXIDE	Absolutely Natural	70fac4d6-8833-4799-b6b6-796f8f13f80e	2024-06-25	Warnings	Exact identifier application number: M016
Medicated Body	MENTHOL AND ZINC OXIDE	Universal Distribution Center LLC	2a59a847-cc7a-42cf-b49a-92e7254c1629	2024-06-19	Warnings	Exact identifier application number: M016
THERA Moisturizing Body Shield	DIMETHICONE	McKesson Medical-Surgical Inc.	56869b64-11ee-4df6-8102-ce5818e0116e	2024-06-18	Warnings	Exact identifier application number: M016
Dimethicone	SKIN PROTECTANT	McKesson	96886b33-44d4-5a2a-e053-2a95a90a505e	2024-06-18	Warnings	Exact identifier application number: M016
Derma E Eczema Relief	OATMEAL	derma e	767c4a76-8ccb-4530-9b4b-a7ea1a596c7f	2024-06-18	Warnings	Exact identifier application number: M016
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	Warnings	Exact identifier application number: M016
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E3UT66504P	ALUMINUM SULFATE TETRADECAHYDRATE	16828-12-9	ALUMINUM SULFATE TETRADECAHYDRATE
7ZA48GIM5H	CALCIUM ACETATE MONOHYDRATE	5743-26-0	CALCIUM ACETATE MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250234	aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical Solution	PSN	28c39200-2f7c-954b-3ce7-7349b2738812	10
1293268	Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical Solution	PSN	28c39200-2f7c-954b-3ce7-7349b2738812	10
1293268	aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution [Domeboro]	SBD	28c39200-2f7c-954b-3ce7-7349b2738812	10
1250234	aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution	SCD	28c39200-2f7c-954b-3ce7-7349b2738812	10
1250234	(3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical Solution	SY	28c39200-2f7c-954b-3ce7-7349b2738812	10
1250234	aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical Solution	SY	28c39200-2f7c-954b-3ce7-7349b2738812	10
1293268	Domeboro (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Powder for Topical Solution	SY	28c39200-2f7c-954b-3ce7-7349b2738812	10
1293268	Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical Solution	SY	28c39200-2f7c-954b-3ce7-7349b2738812	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16864-240-01	16864024001	12 POWDER, FOR SOLUTION in 1 BOX (16864-240-01)	2012-06-26	0000-00-00	No	No	Current
16864-240-10	16864024010	100 in 1 BOX					Historical
16864-240-14	16864024014	14 in 1 BOX					Historical