SILICEA

Product NDC
15631-0404
11-digit product format
156310404
Labeler code
15631
Product ID
15631-0404_ca7bbcc8-2354-375c-e053-2995a90a72a0
Type
HUMAN OTC DRUG
Nonproprietary name
SILICEA
Dosage form
PELLET
Route
ORAL
Labeler
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2015-10-02
Substance
SILICON DIOXIDE
Active strength
2 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-4IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage15631-0404-5IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-4IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage15631-0404-5IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-5EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage15631-0404-4EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILICON DIOXIDE2 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0000025c-6dbf-4af7-a741-5cbacaed519aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0404-0SILICEA100 in 1 PACKAGEPELLET1002
15631-0404-1SILICEA200 in 1 PACKAGEPELLET2002
15631-0404-2SILICEA400 in 1 PACKAGEPELLET4002
15631-0404-3SILICEA750 in 1 PACKAGEPELLET7502
15631-0404-4SILICEA2500 in 1 PACKAGEPELLET25002
15631-0404-5SILICEA12500 in 1 PACKAGEPELLET125002
15631-0404-6SILICEA500 in 1 PACKAGEPELLET5002
15631-0404-7SILICEA1000 in 1 PACKAGEPELLET10002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4SILICEA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4SILICEA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1
SUCROSEINACTIVE INGREDIENTC151H8M554SILICEA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0404SILICEA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Current NDC, Legacy NDC, 8 package rows20210903_0000025c-6dbf-4af7-a741-5cbacaed519a.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
SILICEASILICEARxhomeo Private Limited d.b.a. Rxhomeo, Inc0000025c-6dbf-4af7-a741-5cbacaed519a2021-09-02WarningsExact identifier
ndc (product): 15631-0404

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15631-0404-015631040400100 PELLET in 1 PACKAGE (15631-0404-0) 100 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-115631040401200 PELLET in 1 PACKAGE (15631-0404-1) 200 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-215631040402400 PELLET in 1 PACKAGE (15631-0404-2) 400 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-315631040403750 PELLET in 1 PACKAGE (15631-0404-3) 750 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-4156310404042500 PELLET in 1 PACKAGE (15631-0404-4) 2500 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-51563104040512500 PELLET in 1 PACKAGE (15631-0404-5) 12500 pellet2018-01-010000-00-00NoNoCurrent
15631-0404-615631040406500 PELLET in 1 PACKAGE (15631-0404-6) 500 pellet2021-08-230000-00-00NoNoCurrent
15631-0404-7156310404071000 PELLET in 1 PACKAGE (15631-0404-7) 1000 pellet2021-08-230000-00-00NoNoCurrent