FDA.reportPublic FDA data

Dr. Butler Hemorrhoid Treatment

Product NDC
70942-135
11-digit product format
709420135
Labeler code
70942
Product ID
70942-135_3a88f149-6a81-a6a1-e063-6394a90a0043
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine Hydrochloride 0.25%, Witch Hazel 50%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Beyond Health P.A.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-10
Substance
WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength
50; .25 g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Dr. Butler Hemorrhoid Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL50 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599785Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2d1c81c-6443-c4b7-e053-2995a90a14d7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-135-03Dr. Butler Hemorrhoid Treatment1 in 1 CARTONSPRAY14
70942-135-03Dr. Butler Hemorrhoid Treatment85 g in 1 CANSPRAY854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-135DR. BUTLER HEMORRHOID TREATMENT (PHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%) SPRAY [BEYOND HEALTH P.A.]2Current NDC, Legacy NDC, 2 package rows20241217_d2d1c81c-6443-c4b7-e053-2995a90a14d7.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 11 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
application number: M015
Xesso Strawberry Rear Comfort Glide 4% LidocaineLIDOCAINEPremium Natural Cosmetics Incefba09fc-6dd7-0f73-e053-2995a90a628a2025-10-17WarningsExact identifier
application number: M015
medicated padsWITCH HAZELTARGET CORPORATIONacd0d99d-2a77-4227-bebb-c819f4a526662025-10-14WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b0e8d6-4686-960b-e063-6294a90a016e2025-10-09WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
application number: M015
EQUATE HEMORRHOID RELIEFLIDOCAIN 5%WALMART, INCd96e8152-e36e-22fc-e053-2995a90a8b2b2025-10-08WarningsExact identifier
application number: M015
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsExact identifier
application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)LIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.3ffc57c7-5bf4-cba8-e063-6394a90a322f2025-09-29WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation44bb5f25-1114-4bb1-8bcf-40402594abc42025-09-09WarningsExact identifier
application number: M015
Dr. Care Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e456af7-9726-d17e-e063-6394a90ab5602025-09-08WarningsExact identifier
application number: M015
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
application number: M015
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HCLUnifirst First Aid Corporationb3ebf104-cc51-0ef5-e053-2a95a90a25c92025-09-08WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsExact identifier
application number: M015
Pain ReliefANALGESIC MENTHOLUnifirst First Aid Corporation8162d22d-04c0-de07-e053-2991aa0a99752025-09-08WarningsExact identifier
application number: M015
Green Guard BurnLIDOCAINE HCLUnifirst First Aid Corporationb451e96f-fcba-6495-e053-2a95a90a2adf2025-09-08WarningsExact identifier
application number: M015
Lidochill(TM) GelLIDOCAINE HCL 4%, MENTHOL 1%PureTek Corporationd2a9aeb6-8a94-49e7-ab46-84403560b6c82025-09-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e1892de-378b-d2d0-e063-6294a90ad7db2025-09-05WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599785phenylephrine HCl 0.25 % / witch hazel 50 % Rectal SprayPSNd2d1c81c-6443-c4b7-e053-2995a90a14d74
1599785phenylephrine hydrochloride 2.5 MG/ML / witch hazel 500 MG/ML Rectal SpraySCDd2d1c81c-6443-c4b7-e053-2995a90a14d74
1599785phenylephrine hydrochloride 0.25 % / witch hazel 50 % Rectal SpraySYd2d1c81c-6443-c4b7-e053-2995a90a14d74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70942-135-03709420135031 CAN in 1 CARTON (70942-135-03) / 85 g in 1 CAN1 can2021-12-100000-00-00NoNoCurrent