FDA.reportPublic FDA data

Preparation H Cooling Gel

Product NDC
0573-2840
11-digit product format
005732840
Labeler code
0573
Product ID
0573-2840_15581b30-e802-550a-e063-6394a90a3aae
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hcl, witch hazel
Dosage form
GEL
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-01
Substance
PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength
2.5; 500 mg/g; mg/g
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

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2840-10fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0573-2840-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2840-1086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0573-2840-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-2840-10bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0573-2840-20bd6a592717d7…303034d00443…

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
Preparation H Cooling Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
WITCH HAZEL500 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
249465Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0573-2840-102022-12-14Drug Facts
0573-2840-202022-12-14Drug Facts
0573-2840-102022-01-28Drug Facts
0573-2840-202022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2840-10Preparation H Cooling Gel26 g in 1 TUBEGEL269
0573-2840-10Preparation H Cooling Gel1 in 1 CARTONGEL19
0573-2840-20Preparation H Cooling Gel1 in 1 CARTONGEL19
0573-2840-20Preparation H Cooling Gel51 g in 1 TUBEGEL519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2840-10GM - Gram0573-2840644c6680-7646-486f-8f54-c5a0059b4d7912014-01-04
0573-2840-20GM - Gram0573-284096323852-5702-424d-99f5-98a7dc99da5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJPREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]3
witch hazelACTIVE INGREDIENT101I4J0U34PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]3
phenylephrineACTIVE MOIETY1WS297W6MVPREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]3
witch hazelACTIVE MOIETY101I4J0U34PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WYETH CONSUMER HEALTHCARE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2840PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 4 package rows20240406_cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4.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 17 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Rapid Relief HemorrhoidalLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labs00eef84c-a72e-3343-e063-6294a90aa4d82024-12-19WarningsExact identifier
application number: M015
Formula 2 Skin CareLIDOCAINE 5%Derma Care Research Labsa05d5e07-ae4b-38cc-e053-2a95a90abced2024-12-19WarningsExact identifier
application number: M015
Revivol Hemorrhoid and FissureGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0140cf68-b6a0-4378-e063-6394a90afee82024-12-19WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
application number: M015
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
application number: M015
TN Dickinsons Witch Hazel Hemorrhoidal PadsWITCH HAZELDickinson Brands Inc.1b50f4dc-c26a-431a-ae18-c43513871b392024-12-18WarningsExact identifier
application number: M015
RECTICARELIDOCAINEFerndale Laboratories, Inc.49cb48cf-7a26-4d7a-887f-2e98261d269d2024-12-17WarningsExact identifier
application number: M015
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
application number: M015
RECTICARELIDOCAINE AND GLYCERINFerndale Laboratories, Inc.2b94136a-4975-2925-e054-00144ff88e882024-12-17WarningsExact identifier
application number: M015
PRAXPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.674f0d8b-3d50-42b1-8401-d2967bcdf5cf2024-12-17WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
application number: M015
Warrior Rectal CareLIDOCAINE 4%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Derma Care Research Labsfc10cbc3-fc1b-ae09-e053-6394a90ac8f32024-12-15WarningsExact identifier
application number: M015
Tucks Multi-Care Relief Kit (Tucks Hemorrhoidal and Tucks Medicated Cooling 40 Count)GLYCERIN, LIDOCAINE, AND WITCH HAZELBlistex Inca7cb6d78-3048-43b3-afe7-4d862fdcfd3f2024-12-13WarningsExact identifier
application number: M015
Tucks Medicated Cooling PadsWITCH HAZELBlistex Incb3e68008-3d0d-4124-9579-b503e9fb95c92024-12-13WarningsExact identifier
application number: M015
T.N. Dickinsons Witch Hazel Medicated Cooling Pads Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.2a4273a4-3bda-4653-a065-cd4578053f3c2024-12-12WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELMedical Products Laboratories, Inc.b815792f-2f8f-7ac8-e053-2995a90ade182024-12-11WarningsExact identifier
application number: M015
ZensaLIDOCAINEAlera Skin Care Products Inc.f56146b6-3c11-4608-a6ab-6142f27e9ac32024-11-24WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSNcebee3f7-8591-e4f7-e66a-e43b4ba3aaf49
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCDcebee3f7-8591-e4f7-e66a-e43b4ba3aaf49
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSYcebee3f7-8591-e4f7-e66a-e43b4ba3aaf49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-2840-10005732840101 TUBE in 1 CARTON (0573-2840-10) / 26 g in 1 TUBE1 tube2004-01-010000-00-00NoNoCurrent
0573-2840-20005732840201 TUBE in 1 CARTON (0573-2840-20) / 51 g in 1 TUBE1 tube2004-01-010000-00-00NoNoCurrent