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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d2ecb86-6bb1-2528-e063-6394a90a8d892025-08-25WarningsExact identifier
application number: M015
Cooling Perineal Pad LinersCOOLING PERINEALELEEO BRANDS LLC29a433bc-a833-ffc7-e063-6294a90a465a2025-08-25WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d3b771f-5e30-b23e-e063-6294a90a3fb22025-08-25WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
application number: M015
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
application number: M015
Lidocaine PatchLIDOCAINE 4%SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS0a31ba9a-8283-4bf8-b6c6-6e331465622f2025-08-20WarningsExact identifier
application number: M015
VBBV Anorectal(Hemorrhoidal) CreamsLIDOCAINEJiashen International Trading Co., Ltd.3cba84ea-5ee0-7ee3-e063-6294a90af11b2025-08-19WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
application number: M015
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
application number: M015
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
application number: M015
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
application number: M015
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
application number: M015
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
application number: M015
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
application number: M015
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
application number: M015
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
application number: M015
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact 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