FDA.reportPublic FDA data

Rapidol

Manufacturer
Pharmadel LLC
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:34:32

Label at a glance#

ProductRapidol
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites poison ivy poison oak poison sumac soaps detergent cosmetics jewelry seborrheic dermatitis psoriasis and for external feminine, genital, and anal itching for other uses of this product should only be under the advice and supervision of a doctor

Dosage and administration

For itchy skin, irritations, inflammation, rashes and external feminine and genital itching: adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. children under 2 years of age: do not use, consult a doctor For external anal itching: adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blo...

Storage and handling

store in a cool dry place do not use if foil seal under cap is torn, broken, or missing

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose

Hydrocortisone 1%...............................................

Anti-itch

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergent
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • and for external feminine, genital, and anal itching
  • for other uses of this product should only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Do not use

OTC - DO NOT USE SECTION

  • for treatment of diaper rash. Consult a doctor
  • if you have a vaginal discharge. Consult a doctor.
  • with any other hydrocortisone product unless you have consulted a doctor

When using this product

OTC - WHEN USING SECTION

  • for external anal itching: Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days and occur again within a few days

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

For itchy skin, irritations, inflammation, rashes and external feminine and genital itching:

  • adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor

For external anal itching:

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by

patting or blotting with toilet tissue or a soft cloth before application of this product.

  • children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store in a cool dry place
  • do not use if foil seal under cap is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe vera, ceteareth-20, cetostearyl alcohol, chlorocresol, edetate disodium, glyceryl monostearate, mineral oil, propylene glycol, sodium metabisulfite, tocopherol acetate (vitamin E), water

Questions?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

Dist. by/ por

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720 • www.pharmadel.com

+1-866-359-3478

Made in India / Hecho en India

†This product is not manufactured or distributed by Chattem, Inc. a division of Sanofi owner of the Cortizone-10® trademark.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hydrocortisone PDPhydrocortisone PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN6
106258hydrocortisone 10 MG/ML Topical CreamSCD6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY6
106258hydrocortisone 1 % Topical CreamSY6
106258hydrocortisone 1 GM per 100 GM Topical CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-420-02Rapidol1 in 1 CARTONCREAM16
55758-420-02Rapidol60 g in 1 TUBECREAM606
55758-420-03Rapidol1 in 1 CARTONCREAM16
55758-420-03Rapidol57 g in 1 TUBECREAM576

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-42055758-420-02, 55758-420-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROCORTISONEWI4X0X7BPJACTIB
CHLOROCRESOL36W53O7109IACT
SODIUM METABISULFITE4VON5FNS3CIACT
CETEARETH-20YRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RapidolHYDROCORTISONEPharmadel LLC19a1f1e2-bc6b-7153-e063-6294a90ab1152026-01-23WarningsExact identifier
ndc (package): 55758-420-03
ndc (package): 55758-420-02
ndc (product): 55758-420
ndc11 (package): 55758042002
ndc11 (package): 55758042003
spl id: 491142b7-44da-7a1a-e063-6394a90a1942
spl set id: 19a1f1e2-bc6b-7153-e063-6294a90ab115

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.