Evamist

Product NDC: 0574-2067
11-digit product format: 005742067
Labeler code: 0574
Product ID: 0574-2067_2da3b881-d6b1-4996-889b-cd882108af38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: SPRAY
Route: TRANSDERMAL
Labeler: Padagis US LLC
Application: NDA022014
Marketing category: NDA
Marketing start: 2015-04-11
Substance: ESTRADIOL
Active strength: 1.53 mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022014-001	EVAMIST	ESTRADIOL	1.53MG/SPRAY	SPRAY / TRANSDERMAL		RLD, RS	2007-07-27

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022014-001	EVAMIST	1.53MG/SPRAY	SPRAY / TRANSDERMAL	RLD, RS	2007-07-27	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022014-001	6978945	2022-07-31	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022014-001	6978945	2022-07-31	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022014-001	6978945	2022-07-31	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022014-001	6978945	2022-07-31	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022014-001	6978945	2022-07-31	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022014-001	6978945	2022-07-31	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022014-001	6978945	2022-07-31	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022014-001	6978945	2022-07-31	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022014-001	6978945	2022-07-31	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022014-001	6978945	2022-07-31	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022014-001	6978945	2022-07-31	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022014-001	6978945	2022-07-31	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022014-001	6978945	2022-07-31	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N022014-001	6978945	2022-07-31	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022014-001	6978945	2022-07-31	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022014-001	6978945	2022-07-31	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022014-001	6978945	2022-07-31	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022014-001	6978945	2022-07-31	Drug product	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Evamist
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	1.53 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
728118	Internal RxNorm lookup
728122	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9a0aa631-133d-406b-9d32-8a1a99af4e50	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0574-2067-00	Evamist	56 in 1 VIAL, MULTI-DOSE	SPRAY	56		9
0574-2067-27	Evamist	56 in 1 VIAL, MULTI-DOSE	SPRAY	56		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-2067-27	ML - Milliliter	0574-2067	0d363920-4f0e-4b8d-93d0-d41df87b3c2c	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	EVAMIST (ESTRADIOL) SPRAY [PADDOCK LABORATORIES, LLC]	1
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	EVAMIST (ESTRADIOL) SPRAY [PADDOCK LABORATORIES, LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	EVAMIST (ESTRADIOL) SPRAY [PADDOCK LABORATORIES, LLC]	1
OCTISALATE	INACTIVE INGREDIENT	4X49Y0596W	EVAMIST (ESTRADIOL) SPRAY [PADDOCK LABORATORIES, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-2067	EVAMIST (ESTRADIOL) SPRAY [PADAGIS US LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241101_9a0aa631-133d-406b-9d32-8a1a99af4e50.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Evamist	ESTRADIOL	Padagis US LLC	9a0aa631-133d-406b-9d32-8a1a99af4e50	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022014 application number: NDA022014 ndc (product): 0574-2067

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
728118	estradiol 1.53 MG/ACTUAT (1.7 % ) Topical Spray	PSN	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728122	Evamist 1.53 MG/ACTUAT Topical Spray	PSN	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728122	estradiol 1.53 MG/ACTUAT Topical Spray [Evamist]	SBD	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728118	estradiol 1.53 MG/ACTUAT Topical Spray	SCD	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728118	estradiol 1.7 % Topical Spray	SY	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728122	Evamist 1.53 MG/ACTUAT Topical Spray	SY	9a0aa631-133d-406b-9d32-8a1a99af4e50	9
728122	Evamist 1.7 % Topical Spray	SY	9a0aa631-133d-406b-9d32-8a1a99af4e50	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-2067-00	00574206700	56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-00)	56 spray	2015-04-11	0000-00-00	Yes	No	Current
0574-2067-27	00574206727	56 SPRAY in 1 VIAL, MULTI-DOSE (0574-2067-27)	56 spray	2015-04-11	0000-00-00	No	No	Current