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 |
|---|---|---|---|---|---|---|
| EIGHT HOUR SKIN FRAGRANCE FREE | PETROLATUM | REVLON | b61d6e2e-18dd-37d2-e053-2a95a90af57b | 2025-08-01 | Warnings | M016 |
| Vigority Wild Yam Cream | ESTRIOL CREAM | FOUNDATION COMMERCE INC | 39b2bef7-46c5-9ad5-e063-6294a90ae983 | 2025-07-30 | Warnings | M016 |
| Rugby Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Rugby Laboratories | 9af3a740-ef97-26ce-e053-2a95a90a0ee1 | 2025-07-28 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | e7eb10b7-3950-49cb-ba73-11e7581b6be9 | 2025-07-25 | Warnings | M016 |
| ProCure SkinGuard | PETROLATUM 49.9% | Twin Med LLC | 3a1721f6-1bb0-cd47-e063-6394a90a148e | 2025-07-25 | Warnings | M016 |
| ProCure HydroCerin | PETROLATUM 33% | Twin Med LLC | 3ab7248d-b914-9fdd-e063-6294a90ac4c8 | 2025-07-24 | Warnings | M016 |
| AD PREVENT Original | AD PREVENT ORIGINAL | WellSpring Pharmaceutical Corporation | cf73246e-81c1-42e9-a107-dc6c99cf7d01 | 2025-07-24 | Warnings | M016 |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | M016 |
| Dr Butlers Soothing Incontinence | MINERAL OIL 59.8%, PETROLATUM 36.0% | Beyond Health PA | 3a9d3796-fd05-fe57-e063-6294a90a0ac6 | 2025-07-23 | Warnings | M016 |
| A and D plus E | VITAMIN A, D AND E OINTMENT | Derma Sciences Canada Inc. | 35aca592-bfd0-652f-e063-6394a90ac53e | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | 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 |