FDA.reportPublic FDA data

Signature Care Hemorrhoidal

Product NDC
21130-628
11-digit product format
211300628
Labeler code
21130
Product ID
21130-628_b7cd29c2-2153-4c4f-8fd6-1b974d262981
Type
HUMAN OTC DRUG
Nonproprietary name
cocoa butter, phenylephrine HCl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Safeway
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-62821130-628-53DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
Signature Care 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
e74b71a1-915d-4e5b-b548-d5cce7945dbdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-628-53Signature Care Hemorrhoidal12 in 1 CARTONSUPPOSITORY125
21130-628-53Signature Care Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15
21130-628-62Signature Care Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY15
21130-628-62Signature Care Hemorrhoidal24 in 1 CARTONSUPPOSITORY245

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COCOA BUTTERACTIVE INGREDIENT512OYT1CRRSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
COCOA BUTTERACTIVE MOIETY512OYT1CRRSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-628SIGNATURE CARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [SAFEWAY]5Current NDC, Legacy NDC, 4 package rows20241025_e74b71a1-915d-4e5b-b548-d5cce7945dbd.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 9 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
application number: M015
CVS Maximum OTC Strength Hemorrhoidal with AloeGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY,INCb55c63fb-5dfa-4567-8192-58f4038688372026-01-02WarningsExact identifier
application number: M015
HemRid Anorectal CreamLIDOCAINEKKA & Associates LLCdbeb4325-3e85-1147-e053-2995a90a21602025-12-31WarningsExact identifier
application number: M015
ElixirCurozoleCLOTRIMAZOLEELIXIR HEALTHCARE USA, LLC.0c468a9e-d092-4704-b742-92ecd99182092025-12-26WarningsExact identifier
application number: M015
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
application number: M015
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC40fde50a-3cc0-4286-9b33-8f3912254c332025-12-18WarningsExact identifier
application number: M015
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
application number: M015
topcare hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLTopco Associates LLC81a3546b-5099-4b9a-b774-b3e79316b2672025-12-13WarningsExact identifier
application number: M015
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
application number: M015
LMX5LIDOCAINEFerndale Laboratories, Inc.34f8ed6b-4a52-4a99-9c1b-254196dc29b02025-12-10WarningsExact identifier
application number: M015
PURAWITCH HAZELMypura.com Limited1523f52f-6a5b-a12d-e063-6294a90a44962025-12-05WarningsExact identifier
application number: M015
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEMarlex Pharmaceuticals, Inc.c24e2dab-cab4-38f4-e053-2995a90aabae2025-12-04WarningsExact identifier
application number: M015
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
application number: M015
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
application number: M015
Meicated WipeWITCH HAZELDiamond Wipes International, Inc4458c80c-d013-55ba-e063-6394a90a6b392025-11-24WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
application number: M015
Launch MedicalLIDOCAINE HYDROCHLORIDESambria Pharmaceuticals, LLC293ef514-44c1-43ac-9a81-c30e34ad39e52025-11-12WarningsExact identifier
application number: M015
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
application number: M015
Hazel Perineal Healing FoamWITCH HAZELJiangsu Senwo Medical Technology Co., Ltd.314b75cb-affe-a248-e063-6294a90a47b72025-11-07WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSNe74b71a1-915d-4e5b-b548-d5cce7945dbd5
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCDe74b71a1-915d-4e5b-b548-d5cce7945dbd5
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySYe74b71a1-915d-4e5b-b548-d5cce7945dbd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-628-532113006285312 BLISTER PACK in 1 CARTON (21130-628-53) > 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack2015-11-030000-00-00NoNoCurrent
21130-628-622113006286224 BLISTER PACK in 1 CARTON (21130-628-62) / 1 SUPPOSITORY in 1 BLISTER PACK24 blister pack2015-11-030000-00-00NoNoCurrent