Bisacodyl Laxative

Product NDC
13709-328
11-digit product format
137090328
Labeler code
13709
Product ID
13709-328_3908d3b4-6bfd-dc73-e063-6294a90a5088
Type
HUMAN OTC DRUG
Nonproprietary name
Bisacodyl Laxative Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-23
Substance
BISACODYL
Active strength
10 mg/1.8g
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

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
Bisacodyl Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISACODYL10 mg/1.8g

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
198509Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35cb0386-a662-6893-e063-6294a90aa71aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-328-01Bisacodyl Laxative30 in 1 CARTONSUPPOSITORY303
13709-328-01Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-02Bisacodyl Laxative5 in 1 CARTONSUPPOSITORY53
13709-328-02Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative10 in 1 CARTONSUPPOSITORY103

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 15 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Anal Glide ExtraBENZOCAINEPRODUCT MAX GROUP INC282ac8d3-2caf-42de-b347-450e9c7a9e502025-04-03WarningsExact identifier
application number: M015
Numb 520LIDOCAINEClinical Resolution Laboratory, Inc.984c4bee-0d44-4e0f-a057-0d54400c4cac2025-04-02WarningsExact identifier
application number: M015
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
application number: M015
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
application number: M015
Numb and Number Anorectal CreamLIDOCAINEDermtech Labs, Inc31420635-5021-173d-e063-6294a90a407a2025-03-26WarningsExact identifier
application number: M015
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
application number: M015
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
application number: M015
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
application number: M015
Numbskin Maximum Strength Pain RelieverLIDOCAINEShinpharma Inc2f288bde-99fd-42f8-e063-6394a90a0f052025-02-27WarningsExact identifier
application number: M015
PREPARATION H TOTABLES IRRITATION RELIEF WIPESWITCH HAZELHaleon US Holdings LLC1953ec64-20ce-488b-8f14-44e15cc9e7202025-02-21WarningsExact identifier
application number: M015
LBRI STOP THE PAIN Super Aloe Pain Relief CreamMENTHOL, METHYL SALICYLATEL'BRI HEALTH AND BEAUTY INC62e18a37-c0db-4b1e-a6a1-35684cc00e082025-01-28WarningsExact identifier
application number: M015
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
application number: M015
lidocaineLIDOCAINENivagen Pharmaceuticals, Inc.32964ec3-1880-477b-9f71-2222c39106aa2025-01-23WarningsExact identifier
application number: M015
Hemorrhoidal cocoa butterHEMORRHOIDALNeilMed Pharmaceuticals Inc.03b159b0-b960-b38d-e063-6394a90a94622025-01-17WarningsExact identifier
application number: M015
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN BASED GENTLE AND EFFECTIVE LAXATIVE ADULT CONSTIPATION RELIEFNeilMed Pharmaceuticals Inc.03b4be69-6488-76be-e063-6394a90a7edf2025-01-17WarningsExact identifier
application number: M015
Pre-moistened Medicated Wipes, Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal Astringent, Walgreens Pre-moistened Medicated Wipes, Walgreens Pre-moistened Medicated Wipes Witch Hazel 50%/Hemorrhoidal AstringentWITCH HAZELWalgreens Company209a111b-d169-cb5d-e063-6394a90a33ca2025-01-15WarningsExact identifier
application number: M015
Pre-moistened Medicated Pads, Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch Hazel, Walgreens Pre-moistened Medicated Pads, Walgreens Pre-moistened Medicated Pads Hemorrhoidal Pads with Witch HazelWITCH HAZELWalgreens Company1e2dcec1-a1fe-71d2-e063-6394a90a99082025-01-15WarningsExact identifier
application number: M015
AER Pre-moistened Witch Hazel PadWITCH HAZELBirchwood Laboratories LLC1cca622f-0a6b-4f35-9355-34c249ee705e2025-01-14WarningsExact identifier
application number: M015
B-SURE Traveler ToweletteB-SURE TRAVELERBirchwood Laboratories LLCe1a5da94-6a1a-497b-a737-1c1541bf04042025-01-14WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN35cb0386-a662-6893-e063-6294a90aa71a3
198509bisacodyl 10 MG Rectal SuppositorySCD35cb0386-a662-6893-e063-6294a90aa71a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-328-011370903280130 BLISTER PACK in 1 CARTON (13709-328-01) / 1.8 g in 1 BLISTER PACK30 blister pack2025-05-23NoNoCurrent
13709-328-02137090328025 BLISTER PACK in 1 CARTON (13709-328-02) / 1.8 g in 1 BLISTER PACK5 blister pack2025-05-23NoNoCurrent
13709-328-031370903280310 BLISTER PACK in 1 CARTON (13709-328-03) / 1.8 g in 1 BLISTER PACK10 blister pack2025-05-23NoNoCurrent