FDA.reportPublic FDA data

good sense antacid

Product NDC
0113-0851
11-digit product format
001130851
Labeler code
0113
Product ID
0113-0851_457d307b-20a1-4317-98d9-dbe53389de35
Type
HUMAN OTC DRUG
Nonproprietary name
Aluminum hydroxide, Magnesium hydroxide, Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
L. Perrigo Company
Application
part332
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-02-04
Marketing end
0000-00-00
Substance
ALUMINUM HYDROXIDE; MAGNESIUM HYDROXIDE; DIMETHICONE
Active strength
400 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0851-40ML - Milliliter0113-085172cf17a5-6617-4e96-aaaa-78673b22331412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALUMINUM HYDROXIDEACTIVE INGREDIENT5QB0T2IUN0MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004SMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM HYDROXIDEACTIVE MOIETY5QB0T2IUN0MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM HYDROXIDEACTIVE MOIETYNBZ3QY004SMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMAALOX ANTACID (ALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE) LIQUID [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSN60518af3-965f-4d00-853a-9551fc3c398c1
307746aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral SuspensionPSNe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
210031Maalox Advanced 200 MG / 200 MG / 20 MG in 5 mL Oral SuspensionPSNe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
210031aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension [Maalox Plus]SBDe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCD60518af3-965f-4d00-853a-9551fc3c398c1
307746aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral SuspensionSCDe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSY60518af3-965f-4d00-853a-9551fc3c398c1
307746aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral SuspensionSYe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSY60518af3-965f-4d00-853a-9551fc3c398c1
307746aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral SuspensionSYe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSY60518af3-965f-4d00-853a-9551fc3c398c1
307746aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral SuspensionSYe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
210031Maalox Advanced (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 20 MG) per 5 ML Oral SuspensionSYe2a14762-3860-44c3-a3ea-5dbc45f4b1d51
210031Maalox Plus (aluminum hydroxide 40 MG / milk of magnesia 40 MG / simethicone 4 MG) per ML Oral SuspensionSYe2a14762-3860-44c3-a3ea-5dbc45f4b1d51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0851-4000113085140355 mL in 1 BOTTLE (0113-0851-40) 355 ml2003-02-040000-00-00NoNoCurrent