FDA.reportPublic FDA data

Domeboro

Product NDC
16864-240
Requested package NDC
16864-240-01
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

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
IngredientStrength
ALUMINUM SULFATE TETRADECAHYDRATE1347 mg/1
CALCIUM ACETATE MONOHYDRATE952 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E3UT66504PInternal UNII lookup
7ZA48GIM5HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1250234Internal RxNorm lookup
1293268Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28c39200-2f7c-954b-3ce7-7349b2738812Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-240-01Domeboro12 in 1 BOXPOWDER, FOR SOLUTION1210
16864-240-10Domeboro100 in 1 BOXPOWDER, FOR SOLUTION10010
16864-240-14Domeboro14 in 1 BOXPOWDER, FOR SOLUTION1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-240-01EA - Each16864-240200554ae-f5db-4804-9910-4246fe5f661912020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM SULFATE TETRADECAHYDRATEACTIVE INGREDIENTE3UT66504PDOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]2
CALCIUM ACETATE MONOHYDRATEACTIVE INGREDIENT7ZA48GIM5HDOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]2
ALUMINUM CATIONACTIVE MOIETY3XHB1D032BDOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]2
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBDOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [MOBERG PHARMA NORTH AMERICA LLC]2
IcodextrinINACTIVE INGREDIENT2NX48Z0A9GDOMEBORO (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
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-240DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [ADVANTICE HEALTH, LLC.]10Current NDC, Legacy NDC, 3 package rows20241215_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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Eczema Soothing Moisturizing CreamCOLLOIDAL OATMEALNice-Pak Products, LLC23548524-2e2e-4d1a-9ebb-6f86d6279e932026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
application number: M016
Drs. pharmacy Scar CreamALLANTOINOL PHARMA TECH, LLC Drs PHARMACYd0381034-8cf7-5e8d-e053-2995a90a9faa2026-09-09WarningsExact identifier
application number: M016
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
application number: M016
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
application number: M016
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATEUnited Natural Foods, Inc. dba UNFI242adc68-f9e0-4f69-a580-a107d1634b502026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a9aaca8-474a-0393-e063-6394a90a5a3a2026-09-04WarningsExact identifier
application number: M016
Aveeno Eczema Therapy CreamCOLLOIDAL OATMEALKenvue Brands LLC5a7b0470-3ed5-5b92-e063-6294a90ae0f42026-09-03WarningsExact identifier
application number: M016
First Aid Beauty Face and Body Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company5a974dbf-84ac-5374-e063-6294a90a8da02026-09-03WarningsExact identifier
application number: M016
Pure Petrolatum JellyPETROLATUMJell Pharmaceuticals Pvt. Ltd.cdc297cb-476a-6da9-e053-2a95a90a399a2026-09-02WarningsExact identifier
application number: M016
Nail Treatment LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.5a7cd607-a50e-17d0-e063-6294a90acdb22026-09-02WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical SolutionPSN28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical SolutionPSN28c39200-2f7c-954b-3ce7-7349b273881210
1293268aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution [Domeboro]SBD28c39200-2f7c-954b-3ce7-7349b273881210
1250234aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical SolutionSCD28c39200-2f7c-954b-3ce7-7349b273881210
1250234(3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Powder for Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16864-240-011686402400112 POWDER, FOR SOLUTION in 1 BOX (16864-240-01) 2012-06-260000-00-00NoNoCurrent