FDA.reportPublic FDA data

Dulcolax Soft Chews Mixed Berry

Product NDC
41167-0265
11-digit product format
411670265
Labeler code
41167
Product ID
41167-0265_d62e30d3-92a5-4dd4-a475-52c9b016b849
Type
HUMAN OTC DRUG
Nonproprietary name
MAGNESIUM HYDROXIDE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Chattem, Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-23
Substance
MAGNESIUM HYDROXIDE
Active strength
1200 mg/1
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dulcolax Soft Chews Mixed Berry
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM HYDROXIDE1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NBZ3QY004SInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2280709Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe71907c-b1eb-4433-9337-933a944f3e62Available on FDA.report

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
41167-0265-2Dulcolax Soft Chews Mixed Berry90 in 1 BAGTABLET, CHEWABLE909
41167-0265-3Dulcolax Soft Chews Mixed Berry30 in 1 BAGTABLET, CHEWABLE309
41167-0265-6Dulcolax Soft Chews Mixed Berry60 in 1 BAGTABLET, CHEWABLE609
41167-0265-8Dulcolax Soft Chews Mixed Berry15 in 1 BAGTABLET, CHEWABLE159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0265-3EA - Each41167-0265fdff1ad9-bd46-4ce2-8f52-2742b36f67c512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0265DULCOLAX SOFT CHEWS MIXED BERRY (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]7Current NDC, Legacy NDC, 4 package rows20241208_fe71907c-b1eb-4433-9337-933a944f3e62.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 32 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premier Value Milk of MagnesiaMAGNESIUM HYDROXIDEPharmacy Value Alliance, LLCc3cdaa2b-db34-872d-e053-2995a90a38262023-12-20WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
application number: M001
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
application number: M001
Humco Milk of MagnesiaMAGNESIUM HYDROXIDEHumco Holding Group, Inc.b6c90fb4-2673-7e29-e053-2995a90ae9e12023-12-15WarningsExact identifier
application number: M001
Medis Sodium BicarbonateSODIUM BICARBONATEHumco Holding Group, Inc5da32469-58fc-14b1-e053-2a91aa0a74c42023-12-15WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.aa694e0d-7891-4870-8106-dd57f1e29fb42023-12-11WarningsExact identifier
application number: M001
Mylanta One Antacid/Anti-GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONEInfirst Healthcare Inc.ed1b03f0-fabc-4c1c-8e6d-9f15c380300c2023-12-11WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATERugby Laboratoriese73b5871-4a87-4473-ab00-5e5395be017d2023-12-06WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATE, MAGNESIUM HYDROXIDESato Pharmaceutical Co., Ltd.a6e4475c-dfac-493c-b98a-21473e3b59d52023-12-06WarningsExact identifier
application number: M001
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
application number: M001
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
application number: M001
Inon AceMAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONESato Pharmaceutical Co., Ltd.0af4355f-e160-409d-8471-2de98dbc6f7c2023-11-10WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd00ead8-026c-6610-e053-6394a90a0f112023-11-08WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONESTRATEGIC SOURCING SERVICES LLCfd67566a-1078-019d-e053-6394a90a415c2023-11-08WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONESTRATEGIC SOURCING SERVICES LLCfd7a0a90-6570-c722-e053-6394a90a03f42023-11-08WarningsExact identifier
application number: M001
GERI-LANTA SUPREME CHERRYCALCIUM CARBONATE, MAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp7fbc654b-a0d4-408c-bb5a-eb50b7b543822023-11-08WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d6916ec-e87f-6421-e053-2991aa0a33642023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d68366d-fee9-2acf-e053-2991aa0a7e4b2023-11-07WarningsExact identifier
application number: M001
ANTACID ANTIGAS NTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5d7ed0c5-911c-299a-e053-2a91aa0aae562023-11-07WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION5e1eed65-0d4c-2d02-e053-2991aa0a95c12023-11-07WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2280709magnesium hydroxide 1200 MG Chewable TabletPSNfe71907c-b1eb-4433-9337-933a944f3e629
2280709magnesium hydroxide 1200 MG Chewable TabletSCDfe71907c-b1eb-4433-9337-933a944f3e629

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41167-0265-24116702650290 TABLET, CHEWABLE in 1 BAG (41167-0265-2) 2026-04-01NoNoCurrent
41167-0265-34116702650330 TABLET, CHEWABLE in 1 BAG (41167-0265-3) 2020-02-230000-00-00NoNoCurrent
41167-0265-64116702650660 TABLET, CHEWABLE in 1 BAG (41167-0265-6) 2020-02-230000-00-00NoNoCurrent
41167-0265-84116702650815 TABLET, CHEWABLE in 1 BAG (41167-0265-8) 2021-01-010000-00-00NoNoCurrent