Alumox

Product NDC: 53041-152
11-digit product format: 530410152
Labeler code: 53041
Product ID: 53041-152_5d40d267-819d-4da4-b65f-7e4c1f407e2a
Type: HUMAN OTC DRUG
Nonproprietary name: Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Guardian Drug Company
Application: part331
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-06-06
Marketing end: 0000-00-00
Substance: ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength: 200 mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53041-152		I	Inactivated by FDA		2026-09-09
excluded package	package	53041-152	53041-152-16	I	Inactivated by FDA		2026-09-09

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53041-152-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53041-152-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53041-152-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53041-152-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53041-152-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53041-152-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53041-152-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53041-152-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53041-152-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53041-152-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53041-152-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53041-152-16	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53041-152-16	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53041-152-16	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53041-152-16	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53041-152-16	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53041-152-16	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53041-152-16	`bd6a592717d7…`	`303034d00443…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53041-152-16	2022-01-28	C162847	48780-1	d6a99b39-a008-a426-e053-dadaa90af4c2	Guardian Alumox Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53041-152-16	Alumox	100 in 1 BOTTLE	TABLET, CHEWABLE	100		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALUMINUM HYDROXIDE	ACTIVE INGREDIENT	5QB0T2IUN0	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
ALUMINUM HYDROXIDE	ACTIVE MOIETY	5QB0T2IUN0	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
MAGNESIUM CATION	ACTIVE MOIETY	T6V3LHY838	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
RAW SUGAR	INACTIVE INGREDIENT	8M707QY5GH	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53041-152	ALUMOX (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) TABLET, CHEWABLE [GUARDIAN DRUG COMPANY]	2	Legacy NDC, 1 package rows	20200118_43b1de44-32f2-4793-bf60-321c81bb2e3b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QB0T2IUN0	ALUMINUM HYDROXIDE	21645-51-2	ALUMINUM HYDROXIDE
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307747	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet	PSN	43b1de44-32f2-4793-bf60-321c81bb2e3b	2
307747	aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet	SCD	43b1de44-32f2-4793-bf60-321c81bb2e3b	2
307747	aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG Chewable Tab	SY	43b1de44-32f2-4793-bf60-321c81bb2e3b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53041-152-16	53041015216	100 TABLET, CHEWABLE in 1 BOTTLE (53041-152-16)	2004-06-06	0000-00-00	No	No	Current