FDA.reportPublic FDA data

Gentle Overnight Laxative

Product NDC
21130-827
11-digit product format
211300827
Labeler code
21130
Product ID
21130-827_ab6605a8-565c-49be-8383-d2ee30110d79
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Better Living Brands, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-03
Marketing end
2027-08-31
Substance
BISACODYL
Active strength
5 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-82721130-827-06DDiscontinued by firm2026-08-07
excluded packagepackage21130-82721130-827-56DDiscontinued by firm2026-08-07

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 · 11 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0521130-827-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0521130-827-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2621130-827-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2621130-827-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3121130-827-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2821130-827-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2121130-827-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1021130-827-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3121130-827-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2021130-827-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1021130-827-560efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Gentle Overnight Laxative

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
10X0709Y6IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
350e3214-2252-4f4f-89b7-386edcfd7bf2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-827-06Gentle Overnight Laxative200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE2009
21130-827-06Gentle Overnight Laxative1 in 1 CARTONTABLET, DELAYED RELEASE19
21130-827-12Gentle Overnight Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE259
21130-827-12Gentle Overnight Laxative4 in 1 CARTONTABLET, DELAYED RELEASE49
21130-827-56Gentle Overnight Laxative1 in 1 CARTONTABLET, DELAYED RELEASE19
21130-827-56Gentle Overnight Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-827GENTLE OVERNIGHT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [BETTER LIVING BRANDS, LLC]9Current NDC, Legacy NDC, 6 package rows20250430_350e3214-2252-4f4f-89b7-386edcfd7bf2.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentle Overnight LaxativeBISACODYLBetter Living Brands, LLC350e3214-2252-4f4f-89b7-386edcfd7bf22025-04-29WarningsExact identifier
ndc (product): 21130-827

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN350e3214-2252-4f4f-89b7-386edcfd7bf29
308753bisacodyl 5 MG Delayed Release Oral TabletSCD350e3214-2252-4f4f-89b7-386edcfd7bf29
308753bisacodyl 5 MG Enteric Coated Oral TabletSY350e3214-2252-4f4f-89b7-386edcfd7bf29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-827-06211300827061 BOTTLE, PLASTIC in 1 CARTON (21130-827-06) > 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2020-02-030000-00-00NoNoCurrent
21130-827-12211300827124 BLISTER PACK in 1 CARTON (21130-827-12) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK4 blister pack2020-02-032027-08-31NoNoCurrent
21130-827-56211300827561 BLISTER PACK in 1 CARTON (21130-827-56) > 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2020-02-030000-00-00NoNoCurrent