FDA.reportPublic FDA data

Dulcolax

Product NDC
41167-0291
11-digit product format
411670291
Labeler code
41167
Product ID
41167-0291_83a1c2ce-4608-4e74-b3d7-05c3e1295cd5
Type
HUMAN OTC DRUG
Nonproprietary name
Magnesium hydroxide
Dosage form
LIQUID
Route
ORAL
Labeler
Chattem, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-01
Substance
MAGNESIUM HYDROXIDE
Active strength
1200 mg/15mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dulcolax
Brand name suffix
Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE1200 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNBZ3QY004S
Rxcui253017

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0291-0DulcolaxLiquid354 mL in 1 BOTTLELIQUID3547

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0291-0ML - Milliliter41167-029178a929f8-f4ab-45fc-8143-921942338ef412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0291DULCOLAX LIQUID (MAGNESIUM HYDROXIDE) LIQUID [CHATTEM, INC.]7Current NDC, Legacy NDC, 1 package rows20250212_f7acbc8f-9211-48e9-9e5a-7b4a5e158f2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253017magnesium hydroxide 1200 MG in 15 mL Oral SuspensionPSNf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017magnesium hydroxide 80 MG/ML Oral SuspensionSCDf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017magnesium hydroxide 1200 MG per 15 ML Oral SuspensionSYf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017milk of magnesia 2400 MG per 30 ML Oral SuspensionSYf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017milk of magnesia 400 MG per 5 ML Oral SuspensionSYf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017milk of magnesia 8 % Oral SuspensionSYf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7
253017milk of magnesia 80 MG/ML Oral SuspensionSYf7acbc8f-9211-48e9-9e5a-7b4a5e158f2c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0291-041167029100354 mL in 1 BOTTLE (41167-0291-0) 354 ml2019-03-010000-00-00NoNoCurrent