Ala-Scalp

Product NDC
77052-010
11-digit product format
770520010
Labeler code
77052
Product ID
77052-010_2b39daef-65e8-0aa7-e063-6394a90a364d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocortisone
Dosage form
LOTION
Route
TOPICAL
Labeler
Derm Ventures LLC
Application
ANDA083231
Marketing category
ANDA
Marketing start
2020-07-24
Substance
HYDROCORTISONE
Active strength
20 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083231-001ALA-SCALPHYDROCORTISONE2%LOTION / TOPICALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A083231-001ALA-SCALP2%LOTION / TOPICALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083231-001ALA-SCALP2%LOTION / TOPICALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083231-001ALA-SCALP2%LOTION / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A083231-001ALA-SCALP2%LOTION / TOPICALApproved before 1982cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Ala-Scalp
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197784Internal RxNorm lookup
884077Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61498a40-3b3c-4066-89c8-d99686e2d638Available on FDA.report

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
77052-010-01Ala-Scalp1 in 1 BOXLOTION18
77052-010-01Ala-Scalp29.6 mL in 1 BOTTLE, WITH APPLICATORLOTION29.68
77052-010-02Ala-Scalp59.2 mL in 1 BOTTLE, WITH APPLICATORLOTION59.28
77052-010-02Ala-Scalp1 in 1 BOXLOTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77052-010-01ML - Milliliter77052-010f04a4629-bd38-4b2e-b234-232669181e9612021-10-08
77052-010-02ML - Milliliter77052-0100eeef163-5541-4f21-85f0-f81215215f7e12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77052-010ALA-SCALP (HYDROCORTISONE) LOTION [DERM VENTURES LLC]8Current NDC, Legacy NDC, 4 package rows20250110_61498a40-3b3c-4066-89c8-d99686e2d638.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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONE LOTIONAllegis Holdings LLC1a27d8fa-4025-ed68-e063-6394a90a4f372026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083231
application number: ANDA083231
Ala-ScalpHYDROCORTISONEDerm Ventures LLC61498a40-3b3c-4066-89c8-d99686e2d6382026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083231
application number: ANDA083231
ndc (product): 77052-010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884077Ala-Scalp HP 2 % Topical LotionPSN61498a40-3b3c-4066-89c8-d99686e2d6388
197784hydrocortisone 2 % Topical LotionPSN61498a40-3b3c-4066-89c8-d99686e2d6388
884077hydrocortisone 20 MG/ML Topical Lotion [Ala-Scalp]SBD61498a40-3b3c-4066-89c8-d99686e2d6388
197784hydrocortisone 20 MG/ML Topical LotionSCD61498a40-3b3c-4066-89c8-d99686e2d6388
884077Ala-Scalp 20 MG/ML Topical LotionSY61498a40-3b3c-4066-89c8-d99686e2d6388
884077Ala-Scalp HP 2 % Topical LotionSY61498a40-3b3c-4066-89c8-d99686e2d6388
197784hydrocortisone 2 % Topical LotionSY61498a40-3b3c-4066-89c8-d99686e2d6388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
77052-010-01770520010011 BOTTLE, WITH APPLICATOR in 1 BOX (77052-010-01) / 29.6 mL in 1 BOTTLE, WITH APPLICATOR2021-01-010000-00-00NoNoCurrent
77052-010-02770520010021 BOTTLE, WITH APPLICATOR in 1 BOX (77052-010-02) / 59.2 mL in 1 BOTTLE, WITH APPLICATOR2020-07-240000-00-00NoNoCurrent