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 | 2026-10-16 | |
| excluded package | package | 16864-240 | 16864-240-14 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| Diaper Rash | ZINC OXIDE | Target Corporation | 8059f489-f144-4de5-9454-ac6c1af35dd2 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Coconut Milk and Shea Petroleum Jelly | WHITE PETROLATUM | Target Corporation | c78d9864-92e0-4ad8-8a9b-9752ac6784e8 | 2026-02-18 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 043375b2-e636-4822-9e05-df2327d29986 | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Strategic Sourcing Services LLC | 3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae | 2026-02-17 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 4113bb6e-070a-4116-a8d6-12c6b4475beb | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Valu Merchandisers Company | e5465ddd-e38c-44a4-bb9b-3edbc636576d | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Valu Merchandisers Company | 8b8decec-e921-4ff9-bb49-7e38e34724f6 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Daily Moisturizing | DIMETHICONE | Valu Merchandisers Company | 0cccadd7-11f3-5d1f-e063-6294a90a55c4 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL | Valu Merchandisers Company | 7c6fa37f-79b8-4409-b7a9-3f02332f887a | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | United Natural Foods, Inc. dba UNFI | 014d0028-486e-4f1c-a14f-8162e393ebca | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | United Natural Foods, Inc. dba UNFI | 29a3a719-5e8b-407d-b9d9-bdba26758292 | 2026-02-16 | Warnings, Adverse reactions | M016 |
| Diaper Rash | ZINC OXIDE | Topco Associates LLC | 8acb1b47-70ed-4aa2-a7c0-e807042affc7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | FERRIC OXIDE RED | Topco Associates LLC | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Pure petroleum | WHITE PETROLATUM | Topco Associates LLC | 3babe2cf-9e6c-4f22-940f-c1fdf489f1c7 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Clear Anti Itch | PRAMOXINE HCL, ZINC ACETATE | Topco Associates LLC | 8d3d1ff5-4868-495d-807c-e45aa2176f63 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Healing | PETROLATUM | Topco Associates LLC | b929b159-4af5-4a03-8e7c-676a6ba2bf55 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE, PRAMOXINE HCL | Topco Associates LLC | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Petroleum | WHITE PETROLATUM | Topco Associates LLC | cd7f1727-0b6e-4993-9820-43783994efa1 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Dimethicone | DIMETHICONE | Topco Associates LLC | f37f17f7-f084-4b74-8361-178d2315a476 | 2026-02-13 | Warnings, Adverse reactions | M016 |
| Baby Eczema Therapy | COLLOIDAL OATMEAL | Topco Associates LLC | 4f6af42c-f41e-455f-b94b-3793bf0b9a3f | 2026-02-13 | Warnings, Adverse reactions | 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 |