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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 16864-240 | 16864-240-10 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 16864-240 | 16864-240-14 | D | Discontinued by firm | 2026-10-20 |
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.
| 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 |
|---|---|
| ALUMINUM SULFATE TETRADECAHYDRATE | 1347 mg/1 |
| CALCIUM ACETATE MONOHYDRATE | 952 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| E3UT66504P | Internal UNII lookup |
| 7ZA48GIM5H | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 28c39200-2f7c-954b-3ce7-7349b2738812 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | 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 Billing Units#
| 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 | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Savvy Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE | Savvy Care and Cosmetics | 05ee2662-6a51-6e49-e063-6294a90a4ed7 | 2024-12-19 | Warnings | M016 |
| Health Smart Lavender Baby Petroleum | WHITE PETROLEUM | Home Smart Products | 5828df37-2a42-4129-8e4e-d5ac9c4c9615 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | 980d030a-feaf-4a81-865e-f85c66151380 | 2024-12-19 | Warnings | M016 |
| Baby Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | caf568aa-3889-41ff-835e-875bb6d9ca79 | 2024-12-19 | Warnings | M016 |
| Petroleum Jelly | WHITE PETROLATUM | Rejoice International Inc. | a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95 | 2024-12-19 | Warnings | M016 |
| Cars Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 9905b5a4-382e-4d2a-b971-37998c14c330 | 2024-12-19 | Warnings | M016 |
| Health Smart Aloe Vera Petroleum | WHITE PETROLEUM | Home Smart Products | 2671f2ed-af9d-4234-95bf-def368242a78 | 2024-12-19 | Warnings | M016 |
| DCH Scar | ALLANTOIN 0.5% | Derma Care Research Labs, LLC | 00edbc64-9d32-5751-e063-6294a90a400b | 2024-12-19 | Warnings | M016 |
| Bamboobies Diaper Rash | ZINC OXIDE 15% | Derma Care Research Labs, LLC | 0411f5e3-03d2-c512-e063-6394a90a37d3 | 2024-12-19 | Warnings | M016 |
| Maximum Strength Medicated Foot Powder | MEDICATED FOOT POWDER | Jell Pharmaceuticals Pvt. Ltd. | cdaae985-5363-e9d2-e053-2995a90a2682 | 2024-12-18 | Warnings | M016 |
| BABY FRESH SCENT PETROLEUM | WHITE PETROLEUM | Jell Pharmaceuticals Pvt Ltd. | d80d21cf-9463-7184-e053-2995a90a23f3 | 2024-12-18 | Warnings | M016 |
| Health Smart Baby Petroleum | WHITE PETROLEUM | Home Smart Products | edd9d018-c2c9-4a9a-b727-0a92cd463c02 | 2024-12-18 | Warnings | M016 |
| Health Smart Cocoa Butter Petroleum | WHITE PETROLEUM | Home Smart Products | a65c8267-d34f-4542-a7ca-5180e860a03d | 2024-12-18 | Warnings | M016 |
| Princess Petroleum | WHITE PETROLATUM | Ultra Distributors Inc. | 6d9c92bf-9263-40a4-acac-5c3f0b08c69d | 2024-12-18 | Warnings | M016 |
| Meijer Petroleum Jelly | WHITE PETROLATUM | Meijer Distribution, Inc | b299cf2a-2c6a-68f4-e053-2995a90a5bd7 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen | CALAMINE AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services, LLC | 29945734-4ea6-b702-e063-6294a90ae6f2 | 2024-12-18 | Warnings | M016 |
| Foster and Thrive Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE | Strategic Sourcing Services, LLC | 29946912-9794-8a8e-e063-6394a90a279e | 2024-12-18 | Warnings | M016 |
| Caring Mills Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | fbbfa780-0e2b-1874-e053-6394a90a5eeb | 2024-12-18 | Warnings | M016 |
| Serawise Eczema Rescue | OATMEAL | DrAnaMaria.com LLC | e805866a-2349-4b86-bc83-a7c859cb9403 | 2024-12-18 | Warnings | M016 |
| TheraCare Petroleum Jelly | WHITE PETROLATUM | Veridian Healthcare | d6fad49b-8a49-7f7c-e053-2a95a90ae638 | 2024-12-18 | Warnings | M016 |
DailyMed RxNorm Mappings#
| 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 | 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 |