Home NDC 16864-240 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 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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 65 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GNP Witch Hazel WITCH HAZEL Amerisource Bergen 45ac839d-215d-4c5f-8ae5-5e111d170061 2023-12-14 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin Protectant GLYCERIN L'Oreal USA Products Inc 32eaaaab-41bd-4efe-a71d-92e3a702c1e5 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief OATMEAL COSMETIQUE ACTIVE PRODUCTION e555de17-9b42-4125-a17b-467bc1d179d7 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief OATMEAL L'Oreal USA Products Inc f7b71606-0044-4729-82e8-4514331806a0 2023-12-11 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 GLYCERIN Cosmetique Active Production 01c8a0d5-bcd1-4639-be45-530a226401f0 2023-12-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 34fae56e-367d-4659-af2d-1c9ddaf1639c 2023-12-05 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE Rejoice International Corp. 0ba98cdf-489e-dc2a-e063-6294a90adb38 2023-12-04 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE China Ningbo Shangge Cosmetics Technology Corp. 0baa8a14-8655-d77c-e063-6294a90ab8aa 2023-12-04 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 86472a3d-7138-4141-8422-ab20c17a46e0 2023-12-04 Warnings Exact identifier application number: M016 SOOTHE Moisturizing Rescue Cream OATMEAL Rodan & Fields 91163267-c2aa-47b3-b290-d1605536d806 2023-12-04 Warnings Exact identifier application number: M016 Manzatin-E Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. cafd084f-8493-4d6e-b256-2d4b4282f866 2023-12-01 Warnings Exact identifier application number: M016 Manzatin Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. 5c1618a4-ca08-4814-a556-74e79db618b9 2023-12-01 Warnings Exact identifier application number: M016 Petrolatum Jelly PETROLATUM NEW PRIDE CORP f6634410-fa1f-7987-e053-2995a90abb06 2023-12-01 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair Balm DIMETHICONE Galderma Laboratories, L.P. 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 2023-11-30 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair DIMETHICONE Galderma Laboratories, L.P. 27d74e0f-8359-4c59-bf7f-acade7f4545c 2023-11-30 Warnings Exact identifier application number: M016 Sheffield Advanced Scar Gel ADVANCED SCAR GEL Sheffield Pharmaceuticals LLC ab78b946-81ed-442c-a167-26c26c7fe8a1 2023-11-30 Warnings Exact identifier application number: M016 Akin Diaper Rash ZINC OXIDE Southern Sales & Service, Inc. f5515517-7977-48f9-aab6-cf0d2f2a04a0 2023-11-29 Warnings Exact identifier application number: M016 Dr. Sheffield Diaper Rash ZINC OXIDE Sheffield Pharmaceuticals LLC cac77320-b5cf-4edf-9693-ebabfb61390c 2023-11-28 Warnings Exact identifier application number: M016 Sheffield Zinc Oxide ZINC OXIDE Sheffield Pharmaceuticals LLC 60b54c04-4387-4954-951d-165809947310 2023-11-28 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# 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