GELFOS-M

Product NDC: 73442-0003
Requested package NDC: 73442-0003-1
11-digit product format: 734420003
Labeler code: 73442
Product ID: 73442-0003_96e0edc5-2513-b9e2-e053-2a95a90a266c
Type: HUMAN OTC DRUG
Nonproprietary name: Aluminum Phosphate, Colloidal, Magnesium Hydroxide, Simethicone
Dosage form: LIQUID
Route: ORAL
Labeler: I World Pharmaceutical Co., Ltd.
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-10-08
Marketing end: 0000-00-00
Substance: ALUMINUM PHOSPHATE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength: 12 g/20g; mg/20g; mg/20g
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73442-0003	73442-0003-1	D	Discontinued by firm		2026-10-12

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 · 5 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73442-0003-1	2025-02-13	C162847	48780-1	2cef2736-5bfb-d83d-e063-dadaa90ab31f	96e0edc5-2512-b9e2-e053-2a95a90a266c
73442-0003-1	2025-01-30	C162847	48780-1	2cef2736-5bfb-d83d-e063-dadaa90ab31f	96e0edc5-2512-b9e2-e053-2a95a90a266c

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73442-0003	GELFOS-M (ALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [I WORLD PHARMACEUTICAL CO., LTD.]	2	Legacy NDC	20250216_96e0edc5-2512-b9e2-e053-2a95a90a266c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F92V3S521O	ALUMINUM PHOSPHATE	7784-30-7	ALUMINUM PHOSPHATE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73442-0003-1	73442000301	4 POUCH in 1 PACKAGE (73442-0003-1) > 20 g in 1 POUCH	4 pouch	2019-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GELFOS-M - I World Pharmaceutical Co., Ltd.	I World Pharmaceutical Co., Ltd.	2025-02-12	HUMAN OTC DRUG LABEL	2