FDA.reportPublic FDA data

CALCAREA SULPHURICA

Product NDC
15631-0100
11-digit product format
156310100
Labeler code
15631
Product ID
15631-0100_ce16ada7-6d6a-c045-e053-2995a90a0809
Type
HUMAN OTC DRUG
Nonproprietary name
CALCAREA SULPHURICA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-02
Substance
CALCIUM SULFATE ANHYDROUS
Active strength
1 [hp_X]/1
Pharmacologic classes
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIUM SULFATE ANHYDROUS1 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE934B3V59H

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0100-02021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-12021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-22021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-32021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-42021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-52021-10-11C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-02020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-12020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-22020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-32020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-42020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1
15631-0100-52020-01-31C16284748780-19d75b9d0-d1c2-f424-e053-dadaa90a57ceb0716e48-cc3c-45ab-9281-dcadf74a6ab1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0100-0CALCAREA SULPHURICA100 in 1 PACKAGEPELLET1002
15631-0100-1CALCAREA SULPHURICA200 in 1 PACKAGEPELLET2002
15631-0100-2CALCAREA SULPHURICA400 in 1 PACKAGEPELLET4002
15631-0100-3CALCAREA SULPHURICA750 in 1 PACKAGEPELLET7502
15631-0100-4CALCAREA SULPHURICA2500 in 1 PACKAGEPELLET25002
15631-0100-5CALCAREA SULPHURICA12500 in 1 PACKAGEPELLET125002
15631-0100-6CALCAREA SULPHURICA500 in 1 PACKAGEPELLET5002
15631-0100-7CALCAREA SULPHURICA1000 in 1 PACKAGEPELLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CALCIUM SULFATE ANHYDROUSACTIVE INGREDIENTE934B3V59HCALCAREA SULPHURICA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBCALCAREA SULPHURICA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554CALCAREA SULPHURICA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0100CALCAREA SULPHURICA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Current NDC, Legacy NDC, 8 package rows20211012_b0716e48-cc3c-45ab-9281-dcadf74a6ab1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0100-015631010000100 PELLET in 1 PACKAGE (15631-0100-0) 100 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-115631010001200 PELLET in 1 PACKAGE (15631-0100-1) 200 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-215631010002400 PELLET in 1 PACKAGE (15631-0100-2) 400 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-315631010003750 PELLET in 1 PACKAGE (15631-0100-3) 750 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-4156310100042500 PELLET in 1 PACKAGE (15631-0100-4) 2500 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-51563101000512500 PELLET in 1 PACKAGE (15631-0100-5) 12500 pellet2018-01-010000-00-00NoNoCurrent
15631-0100-615631010006500 PELLET in 1 PACKAGE (15631-0100-6) 500 pellet2021-08-230000-00-00NoNoCurrent
15631-0100-7156310100071000 PELLET in 1 PACKAGE (15631-0100-7) 1000 pellet2021-08-230000-00-00NoNoCurrent