FDA.reportPublic FDA data

foster and thrive hemorrhoidal

Product NDC
70677-1292
11-digit product format
706771292
Labeler code
70677
Product ID
70677-1292_ad6a2264-a9ec-4b76-b091-02552f867ceb
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Strategic Sourcing Services LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2211; 6.5 mg/1; mg/1
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
foster and thrive hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER2211 mg/1
PHENYLEPHRINE HYDROCHLORIDE6.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
512OYT1CRRInternal 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
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb3bc359-b06b-4995-aa68-0117a639dff2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1292-1foster and thrive hemorrhoidal12 in 1 CARTONSUPPOSITORY123
70677-1292-1foster and thrive hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1292-1EA - Each70677-1292d0dff965-99db-41e8-b367-54d77ffa4f2812025-07-08

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 7 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINESainite Trading Shenzhen Co., Ltd.49fcbe81-34b6-5906-e063-6294a90aa65b2026-02-04WarningsExact identifier
application number: M015
Perineal Cooling Pad LinersFRIDA MOM PERINEAL COOLING PAD LINERSFridababy, LLCe9d33d92-34ee-b639-e053-2a95a90a9f362026-02-04WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
application number: M015
careone hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmerican Sales Company46794d2e-8fe6-490d-9cfa-ba9b6c209ad62026-01-29WarningsExact identifier
application number: M015
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
application number: M015
foster and thrive hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLStrategic Sourcing Services LLC9da843f2-e88c-432e-b091-a6acf81d856b2026-01-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLHyVee Incbf1beca0-cc9b-4100-9db7-77f2d1e5497c2026-01-21WarningsExact identifier
application number: M015
GRANULOTION HemorrhoidalMENTHOL, ZINC OXIDEGL Health, Inc.1a32741c-5e4a-40e5-b15a-8233c5bdb92b2026-01-19WarningsExact identifier
application number: M015
HydroseptineZINC OXIDE, MENTHOLAKRON PHARMA INC5359d92e-641e-4076-9d91-18daee58a30e2026-01-19WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL PAIN RELIEFWalgreensb0b1ce47-9fa4-4505-8f38-39a0d500e9f62026-01-15WarningsExact identifier
application number: M015
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
application number: M015
WalgreensHEMORRHOIDAL COOLING GELWalgreens1277d2e8-2a5e-23f5-e063-6294a90a69b02026-01-15WarningsExact identifier
application number: M015
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
application number: M015
MEDPURA Vitamin A and D Vitamin A and DMEDPURA VITAMIN A AND DAkron Pharma Inc.38cc2317-691b-4657-af05-c67623eba7602026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens2dd710ac-ab04-4a24-826f-b5a44d0581682026-01-14WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreensca98dea5-767d-49a8-887b-d96cad487fc42026-01-14WarningsExact identifier
application number: M015
Walgreens Moisture BarrierMENTHOL, AND ZINC OXIDEWalgreen Companya6db6f13-4e02-47dc-aef6-a804506c3d8b2026-01-14WarningsExact identifier
application number: M015
GNP Hemorrhoidal Maximum StrengthHEMORRHOIDALAmerisourcebergen Drug Corporation24103355-cd72-55b0-e063-6394a90a90ec2026-01-14WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNfb3bc359-b06b-4995-aa68-0117a639dff23
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDfb3bc359-b06b-4995-aa68-0117a639dff23
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYfb3bc359-b06b-4995-aa68-0117a639dff23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1292-17067712920112 BLISTER PACK in 1 CARTON (70677-1292-1) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2025-06-11NoNoCurrent