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

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 Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, 101I4J0U34
Rxcui249465

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2840-102022-12-14C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-202022-12-14C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-102022-01-28C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-202022-01-28C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug 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

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