MedPath

Silicon dioxide

Generic Name
Silicon dioxide
Brand Names
Gelusil, Pediacare Gas Relief
Drug Type
Small Molecule
Chemical Formula
O2Si
CAS Number
7631-86-9
Unique Ingredient Identifier
ETJ7Z6XBU4

Overview

Silicon dioxide, or silica, is an oxide of silicon with the chemical formula SiO2. It is found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite as transparent and tasteless crystals. Inhalation of fine crystals is toxic to humans leading to respiratory toxicity. In powdered food products and pharmaceutical tablets, silicon dioxide is added as a flow agent to absorb water. Colloidal silica is also used as a wine, beer, and juice fining agent or stabilizer.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bestmade Natural Products
82969-3018
ORAL
6 [hp_X] in 6 [hp_X]
1/22/2025
Healing Natural Oils LLC
61077-039
TOPICAL
12 [hp_C] in 11 mL
4/8/2025
Peaceful Mountain, Inc.
43846-0039
TOPICAL
30 [hp_X] in 1 g
5/21/2025
Deseret Biologicals, Inc.
43742-2218
ORAL
12 [hp_X] in 1 mL
5/27/2025
ATOSAFE CO., Ltd
85601-020
ORAL
17 g in 100 g
5/7/2025
Martin & Pleasance Pty Ltd
84999-012
ORAL
6 [hp_X] in 30 mL
7/7/2025
BM Private Limited
85816-3025
ORAL
6 [hp_X] in 1 g
7/31/2025
ATOSAFE CO., Ltd
85601-010
ORAL
18 g in 100 g
5/7/2025
King Bio Inc.
57955-9001
ORAL
10 [hp_X] in 59 mL
5/19/2025
King Bio Inc.
57955-5122
ORAL
10 [hp_X] in 59 mL
5/19/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SECALE SILICEA COMP.
02232739
Liquid ,  Pellet - Oral
29 D
4/14/1998
R-57 DPS
dr reckeweg canada
02090384
Drops - Oral
30 D / 10 ML
12/31/1994
R48 DPS
dr reckeweg and co
00857173
Drops - Oral
30 DH / DH
12/31/1989
GOOD NIGHT/PM FORMULA TAB
nikken usa, incorporated
02059541
Tablet - Oral
10 MG
12/31/1995
ADAPTAGEN
bio active canada ltd.
02233546
Liquid - Oral
12 X
5/26/1998
DIATHESIS IV
bio active canada ltd.
02233601
Liquid - Oral
12 X
5/26/1998
VERMOPT
terra botanica products ltd.
02233378
Liquid - Oral
12 X
5/25/1998
S12 SILICEA 3X TAB
dr reckeweg canada
02075113
Tablet - Oral
3 X / TAB
12/31/1994
BAC HP
bio active canada ltd.
02233557
Liquid - Oral
30 X
5/26/1998
BACNIX HP
terra botanica products ltd.
02233299
Liquid - Oral
30 X
5/25/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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