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 50 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 Warnings Exact identifier application number: M016 Softlips Peach Passion DIMETHICONE The Mentholatum Company 4a133e73-e51b-4f04-91de-dc8c4d4dba30 2024-12-17 Warnings Exact identifier application number: M016 Sweet Cheeks Diaper ZINC OXIDE Tubby Todd 4ed0afe1-c893-453e-b4d5-f32561360ec1 2024-12-17 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Geri-Care Pharmaceuticals, Corp f40a29c2-65ea-91f9-e053-2a95a90ac439 2024-12-17 Warnings Exact identifier application number: M016 Vitamin A and D PETROLATUM Geri-care Pharmaceutials Corp fd76c101-a287-f92c-e053-6294a90a4468 2024-12-17 Warnings Exact identifier application number: M016 Foster and Thrive Phenolated Calamine CALAMINE AND ZINC OXIDE AND PHENOL Strategic Sourcing Services LLC 298171e1-2826-d33b-e063-6394a90a875a 2024-12-17 Warnings Exact identifier application number: M016 Secura Dimethicone Protectant DIMETHICONE Smith & Nephew Medical Ltd 83f92ac9-4114-4192-926d-be2854a84106 2024-12-16 Warnings Exact identifier application number: M016 CVS Maximum Strength Anti-Itch Cream HYDROCORTISONE 1% CVS Health c2876cba-d7e7-de5c-e053-2a95a90a6355 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL Blistex Inc 4121d671-521c-4f36-b2db-652c13f730c6 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c 2024-12-16 Warnings Exact identifier application number: M016 Balmex Diaper Rash ZINC OXIDE 11.3% Randob Labs, LTD f7f7a89d-d4e0-9faa-e053-6294a90aaf7b 2024-12-15 Warnings Exact identifier application number: M016 QC Scar ALLANTOIN 0.5% CDMA f7e3d751-a47a-2bca-e053-6394a90a6541 2024-12-15 Warnings Exact identifier application number: M016 Dr. Butler Soothing Incontinence PETROLATUM 36% Beyond Health P.A. d17a0c28-a5b7-4df0-e053-2995a90a8edd 2024-12-15 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