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
2027-12-31
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
2027-12-31

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 18 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid Pain ReliefLIDOCAINETelebrands Corp04164425-ca3b-ef24-e063-6294a90a59d82024-11-20WarningsExact identifier
application number: M015
Hempvana Maximum Strength Pain Relief Topical AnestheticLIDOCAINETelebrands Corpf525075a-d7ee-dad0-e053-2a95a90a6f3f2024-11-20WarningsExact identifier
application number: M015
Curist Lidocaine Numbing ReliefLIDOCAINELittle Pharma, Inc.bff3c422-a0df-6196-e053-2a95a90af0332024-11-20WarningsExact identifier
application number: M015
Hempvana Maximum Strength Pain Relief Topical Anesthetic PlatinumLIDOCAINE 5%Telebrands Corp2774ec41-7366-ac8c-e063-6394a90a1ee22024-11-20WarningsExact identifier
application number: M015
Walgreens Anorectal Lidocaine Cream5% LIDOCAINEWalgreens Company3052fac7-fd68-43f4-9950-8c07288a6b6d2024-11-20WarningsExact identifier
application number: M015
Lidocaine AnorectalLIDOCAINEPatrin Pharma, Inc456d41fe-8449-4980-9291-d7a3b65a900d2024-11-13WarningsExact identifier
application number: M015
MyDermPENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,Inspec Solution LLC.2618eba1-9308-a666-e063-6394a90ac3d22024-11-04WarningsExact identifier
application number: M015
Granulotion MedicatedMENTHOL, ZINC OXIDEGL HEALTH, INC.01701780-b160-415b-b34d-3622371794752024-10-29WarningsExact identifier
application number: M015
rexall hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLDolgencorp Inc0415c51b-5a12-49d4-8968-0131ddb855452024-10-23WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLArmy & Air Force Exchange Service8155ed74-9412-498f-998c-4a29c46e934f2024-10-23WarningsExact identifier
application number: M015
Leader HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leaderc4814524-0f4c-4351-a431-5b4b6431fd282024-10-23WarningsExact identifier
application number: M015
basic care hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLAmazon.com Services LLC617d9213-31f0-4c71-be0c-7961b96e51432024-10-23WarningsExact identifier
application number: M015
Signature Care HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLSafewaye74b71a1-915d-4e5b-b548-d5cce7945dbd2024-10-23WarningsExact identifier
application number: M015
Equaline HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFId29b7824-ff9e-4875-b3de-92721c8add0e2024-10-23WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPublix Super Markets Inca241cb37-7007-4fd8-a12e-f3fc6d6f780e2024-10-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLKroger Companyd44ca22a-dc20-454d-99aa-403a8c7a3e002024-10-22WarningsExact identifier
application number: M015
rugby hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLRugby Laboratoriesc1a126b5-0d34-437f-a7ef-8d5cbeb7b03b2024-10-22WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLMeijer Distribution Inc1431397e-3515-4794-a494-70667948e14c2024-10-18WarningsExact identifier
application number: M015
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
application number: M015
hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLH E B1435432d-5ff2-468b-808d-fb0c99a0717b2024-10-17WarningsExact 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