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 |
|---|---|---|---|---|---|---|
| Colloidal oatmeal | COLLOIDAL OATMEAL | CVS Pharmacy, Inc. | 4a43b1a2-2156-e490-e063-6294a90a6f84 | 2026-04-07 | Warnings, Adverse reactions | M016 |
| Calamine | CALAMINE 8%, ZINC OXIDE 8% | Farmacias De Similares TX LLC | 4ecd0add-11c9-cf3b-e063-6394a90adff6 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | CVS Pharmacy, Inc. | 4dc08832-e610-4e62-a6af-cadaa339e39e | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Witch Hazel | WITCH HAZEL SPRAY | CVS Pharmacy | 53db78a8-eb2d-431b-84c1-73e99bb9d3d1 | 2026-04-06 | Warnings | M016 |
| Petroleum | WHITE PETROLATUM | Amazon.com Services LLC | 616ef87d-1518-46aa-8e12-9a1b678d4980 | 2026-04-06 | Warnings, Adverse reactions | M016 |
| Stabilizing Repair Serum | OATMEAL | Dermalogica, LLC. | 86b7b230-5424-46d3-8058-656f5172fc70 | 2026-04-02 | Warnings | M016 |
| calamine | CALAMINE AND ZINC OXIDE | STRATEGIC SOURCING SERVICES | 4e6a7bdf-4ef1-65e2-e063-6394a90ae124 | 2026-04-01 | Warnings | M016 |
| Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream | COLLOIDAL OATMEAL | Kenvue Brands LLC | 4e4e1797-26e6-a67b-e063-6294a90af438 | 2026-03-31 | Warnings | M016 |
| Target Advanced Scar Gel | ADVANCED SCAR GEL | Target Corporation | 86c215fe-aad4-45d1-bdb7-cde00a115c5c | 2026-03-31 | Warnings | M016 |
| Zinc oxide, Dimethicone | ZINC OXIDE, DIMETHICONE | Walmart Inc. | 4cbf9492-33cd-e6d4-e063-6294a90ab001 | 2026-03-31 | Warnings, Adverse reactions | M016 |
| Critic-Aid Clear | PETROLATUM | Coloplast Corp | a92c18f7-52b2-43e4-bae3-2bab9de22671 | 2026-03-31 | Warnings | M016 |
| 3M Cavilon Durable Barrier | DIMETHICONE | Solventum US LLC | f3f8be33-4ad2-4f5f-ac94-ddfbe0280b83 | 2026-03-31 | Warnings | M016 |
| XIMONTH Foot Sanitizer | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 4e38d24d-3745-c121-e063-6394a90abbb5 | 2026-03-30 | Warnings | M016 |
| Dynashield | ZINC OXIDE | Dynarex Corporation | 59fd865c-b81d-43ad-8fa0-c37ca0557769 | 2026-03-30 | Warnings | M016 |
| First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant | COLLOIDAL OATMEAL | Port Jervis Laboratories, Inc | 4e43b65c-d5bb-f228-e063-6294a90ad08d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4275956d-275a-4e31-e063-6394a90a78d3 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Cherry | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 42762471-e5cd-505e-e063-6294a90afb7d | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Variety Cherry-Strawberry-Spearmint | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 450e46d2-de86-e5fa-e063-6294a90ac6ff | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 4512220a-9fc2-8816-e063-6394a90a9d15 | 2026-03-30 | Warnings | M016 |
| ChapStick Classic Original Military | SKIN PROTECTANT LIP BALM | Suave Brands Co., LLC | 45136b7e-136b-0283-e063-6394a90a599a | 2026-03-30 | 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 |