FDA.reportPublic FDA data

Gentle Laxative

Product NDC
37808-327
11-digit product format
378080327
Labeler code
37808
Product ID
37808-327_97474b3b-3728-43c0-b857-2cfd6a6e47aa
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-03-25
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gentle Laxative
Listing expiration
2027-12-31

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
29c2efc4-d297-46a0-8008-7a2fad9e8b88Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
37808-327-15Gentle Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE2519
37808-327-15Gentle Laxative2 in 1 CARTONTABLET, DELAYED RELEASE219

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
BISACODYLACTIVE MOIETY10X0709Y6IGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
ACACIAINACTIVE INGREDIENT5C5403N26OGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
SHELLACINACTIVE INGREDIENT46N107B71OGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
SUCROSEINACTIVE INGREDIENTC151H8M554GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
TRIACETININACTIVE INGREDIENTXHX3C3X673GENTLE LAXATIVE (BISACODYL) TABLET [H E B]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGENTLE LAXATIVE (BISACODYL) TABLET [H E B]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-327GENTLE LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [H E B]18Current NDC, Legacy NDC, 2 package rows20241122_29c2efc4-d297-46a0-8008-7a2fad9e8b88.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 LaxativeBISACODYLH E B29c2efc4-d297-46a0-8008-7a2fad9e8b882026-07-22WarningsExact identifier
ndc (product): 37808-327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN29c2efc4-d297-46a0-8008-7a2fad9e8b8819
308753bisacodyl 5 MG Delayed Release Oral TabletSCD29c2efc4-d297-46a0-8008-7a2fad9e8b8819
308753bisacodyl 5 MG Enteric Coated Oral TabletSY29c2efc4-d297-46a0-8008-7a2fad9e8b8819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-327-15378080327152 BLISTER PACK in 1 CARTON (37808-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2002-03-250000-00-00NoNoCurrent