FDA.reportPublic FDA data

CALCAREA SULPH

Product NDC
15631-2651
11-digit product format
156312651
Labeler code
15631
Product ID
15631-2651_1a0ec52a-a690-9ad2-e063-6294a90ad7fc
Type
HUMAN OTC DRUG
Nonproprietary name
CALCAREA SULPH
Dosage form
LIQUID
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-05-23
Substance
CALCIUM SULFATE ANHYDROUS
Active strength
1 [hp_X]/mL
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CALCAREA SULPH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM SULFATE ANHYDROUS1 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E934B3V59HInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a0ec763-4fbe-b89f-e063-6394a90ae156Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-2651-0CALCAREA SULPH10 mL in 1 BOTTLELIQUID101
15631-2651-1CALCAREA SULPH30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-2651CALCAREA SULPH LIQUID [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1Current NDC, 2 package rows20240612_1a0ec763-4fbe-b89f-e063-6394a90ae156.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALCAREA SULPHCALCAREA SULPHRxhomeo Private Limited d.b.a. Rxhomeo, Inc1a0ec763-4fbe-b89f-e063-6394a90ae1562024-06-04WarningsExact identifier
ndc (product): 15631-2651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15631-2651-01563126510010 mL in 1 BOTTLE (15631-2651-0) 10 ml2024-05-23NoNoCurrent
15631-2651-11563126510130 mL in 1 BOTTLE (15631-2651-1) 30 ml2024-05-23NoNoCurrent