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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16864-24016864-240-10DDiscontinued by firm2026-10-15
excluded packagepackage16864-24016864-240-14DDiscontinued by firm2026-10-15

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.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0516864-240-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0516864-240-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2616864-240-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2616864-240-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3116864-240-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3116864-240-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2816864-240-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2816864-240-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2116864-240-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2116864-240-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1016864-240-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1016864-240-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3116864-240-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3116864-240-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2016864-240-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2016864-240-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1016864-240-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1016864-240-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0816864-240-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0816864-240-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0316864-240-14367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0316864-240-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0916864-240-14557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0916864-240-10557ba5c1ecfa…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 table
IngredientStrength
ALUMINUM SULFATE TETRADECAHYDRATE1347 mg/1
CALCIUM ACETATE MONOHYDRATE952 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E3UT66504PInternal UNII lookup
7ZA48GIM5HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1250234Internal RxNorm lookup
1293268Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28c39200-2f7c-954b-3ce7-7349b2738812Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-240-01Domeboro12 in 1 BOXPOWDER, FOR SOLUTION1210
16864-240-10Domeboro100 in 1 BOXPOWDER, FOR SOLUTION10010
16864-240-14Domeboro14 in 1 BOXPOWDER, FOR SOLUTION1410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16864-240-01EA - Each16864-240200554ae-f5db-4804-9910-4246fe5f661912020-08-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-240DOMEBORO (ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE) POWDER, FOR SOLUTION [ADVANTICE HEALTH, LLC.]10Current NDC, Legacy NDC, 3 package rows20241215_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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG in 160 ML Topical SolutionPSN28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical SolutionPSN28c39200-2f7c-954b-3ce7-7349b273881210
1293268aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical Solution [Domeboro]SBD28c39200-2f7c-954b-3ce7-7349b273881210
1250234aluminum sulfate 8.42 MG/ML / calcium acetate 5.95 MG/ML Topical SolutionSCD28c39200-2f7c-954b-3ce7-7349b273881210
1250234(3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1250234aluminum sulfate 1347 MG / calcium acetate 952 MG per 160 ML Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (3 Packets (aluminum sulfate 1347 MG Powder / calcium acetate 952 MG Powder)) per 16 OZ Powder for Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210
1293268Domeboro (aluminum sulfate 1347 MG / calcium acetate 952 MG) per 16 OZ Powder for Topical SolutionSY28c39200-2f7c-954b-3ce7-7349b273881210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16864-240-011686402400112 POWDER, FOR SOLUTION in 1 BOX (16864-240-01) 2012-06-260000-00-00NoNoCurrent
16864-240-1016864024010100 in 1 BOXHistorical
16864-240-141686402401414 in 1 BOXHistorical