Narcan

Product NDC: 69547-353
11-digit product format: 695470353
Labeler code: 69547
Product ID: 69547-353_4536fef4-e317-a7fd-e063-6294a90aa0e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naloxone Hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: Emergent Devices Inc.
Application: NDA208411
Marketing category: NDA
Marketing start: 2017-01-24
Substance: NALOXONE HYDROCHLORIDE
Active strength: 4 mg/.1mL
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69547-353	69547-353-02	D	Discontinued by firm		2026-08-11

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208411-001	NARCAN	NALOXONE HYDROCHLORIDE	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18
N208411-002	NARCAN	NALOXONE HYDROCHLORIDE	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208411-002	NARCAN	2MG/SPRAY	SPRAY, METERED / NASAL		RLD	2017-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2015-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208411-001	NARCAN	4MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2015-11-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208411-002	NARCAN	2MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SPRAY, METERED / NASAL		RLD	2017-01-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208411-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208411-001	AB	1	`bb7c543d1eb4…`
2023-01-26 05:58 UTC	2023-01	N208411-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208411-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208411-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208411-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208411-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208411-002	9480644	2035-03-16	U-1903	Drug product, Delist requested	2017-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208411-002	9707226	2035-03-16	U-1903	Drug product, Delist requested	2017-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	10085937	2035-03-16	U-1903		2018-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9211253	2035-03-16		Drug product	2015-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9468747	2035-03-16	U-1903	Drug product	2016-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9561177	2035-03-16	U-1903	Drug product	2017-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9629965	2035-03-16	U-1903	Drug product	2017-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-001	9775838	2035-03-16	U-1903		2017-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	9480644	2035-03-16	U-1903	Drug product	2017-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208411-002	9707226	2035-03-16	U-1903	Drug product	2017-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208411-001	10085937	2035-03-16	U-1903		2018-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9211253	2035-03-16		Drug product	2015-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9468747	2035-03-16	U-1903	Drug product	2016-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9561177	2035-03-16	U-1903	Drug product	2017-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9629965	2035-03-16	U-1903	Drug product	2017-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-001	9775838	2035-03-16	U-1903		2017-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	9480644	2035-03-16	U-1903	Drug product	2017-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208411-002	9707226	2035-03-16	U-1903	Drug product	2017-07-18	`5d02ea3f76ae…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXONE HYDROCHLORIDE	4 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F850569PQR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1725059	Internal RxNorm lookup
1725064	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
724df050-5332-4d0a-9a5f-17bf08a547e1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c955d208-c333-9bd7-be34-d7e12986d44e	Product name	6	20250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304	Product name	1	20250204
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
caa6391e-3db3-c912-335f-61b5fc00aa12	Product name	9	20240110
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
65a3bc34-04ff-4cf1-aad9-c7d92a062f6d	Product name	1	20231003
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
e951cdf3-f269-4d97-a7d5-c1c3d7283a7d	Product name	3	20230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39	Product name	4	20230306
f327b80c-8fa2-404b-838a-df3eec141cf2	Product name	1	20221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119	Product name	1	20220511
b871fccd-1de6-4c7f-b9e5-045304641ee6	Product name	8	20220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9	Product name	1	20211026
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
4c23a34c-e8fc-424c-8fa0-ee064ba6eaef	Product name	1	20170706
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0b8c7273-1da3-495f-909a-7cf1e96d2361	Product name	1	20161212
3df867ed-9d48-45cf-bded-1394beaea0b1	Product name	3	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
8a245632-e24f-4ccc-b671-995d89c96ebc	Product name	1	20141203
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69547-353-02	Narcan	2 in 1 PACKAGE	SPRAY	2		24
69547-353-02	Narcan	0.1 mL in 1 VIAL, SINGLE-DOSE	SPRAY	0.1		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69547-353-02	EA - Each	69547-353	fd96af4f-48c4-4353-b62e-67285d6a56b0	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69547-353	NARCAN (NALOXONE HYDROCHLORIDE) SPRAY NARCAN (NALOXONE HYDROCHLORIDE) SPRAY [EMERGENT DEVICES INC.]	21	Current NDC, Legacy NDC, 2 package rows	20221206_724df050-5332-4d0a-9a5f-17bf08a547e1.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NARCAN	NALOXONE HYDROCHLORIDE NASAL	Sportpharm LLC	3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92	2026-04-24	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN	NALOXONE HYDROCHLORIDE NASAL	Emergent Devices Inc.	a0ebc83d-2892-40de-bc0a-775ce90b30db	2026-04-22	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
Narcan	NALOXONE HYDROCHLORIDE	Emergent Devices Inc.	724df050-5332-4d0a-9a5f-17bf08a547e1	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411 ndc (product): 69547-353
Narcan Naloxone HCL	NARCAN NALOXONE HCL	HF Acquisition Co LLC, DBA HealthFirst	11d770b8-b768-ba3d-e063-6394a90a61a6	2024-02-20	Warnings	Exact identifier application applno (NDA): 208411 application number: NDA208411
Naloxone Hydrochloride	NALOXONE HYDROCHLORIDE NASAL	A-S Medication Solutions	4517afa1-4b17-4a15-b91b-65b18bd0558f	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN NALOXONE HCI	NARCAN NALOXONE HCI	HF Acquisition Co LLC, DBA HealthFirst	784a0e98-c2d6-f845-e053-2991aa0ac4b4	2023-10-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
NARCAN	NALOXONE HYDROCHLORIDE	A-S Medication Solutions	139c30b9-5600-48f5-8610-0cacd2782398	2023-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411
Narcan	NALOXONE HYDROCHLORIDE	Proficient Rx LP	76b5a1ce-e601-457c-ab35-43533bba4394	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208411 application number: NDA208411

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F850569PQR	NALOXONE HYDROCHLORIDE	357-08-4	NALOXONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	139c30b9-5600-48f5-8610-0cacd2782398	28
1725064	NARCAN 4 MG in 0.1 ML Nasal Spray	PSN	139c30b9-5600-48f5-8610-0cacd2782398	28
1725064	naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]	SBD	139c30b9-5600-48f5-8610-0cacd2782398	28
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	139c30b9-5600-48f5-8610-0cacd2782398	28
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	139c30b9-5600-48f5-8610-0cacd2782398	28
1725064	Narcan 40 MG/ML Nasal Spray	SY	139c30b9-5600-48f5-8610-0cacd2782398	28
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725064	NARCAN 4 MG in 0.1 ML Nasal Spray	PSN	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725064	naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]	SBD	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725064	Narcan 40 MG/ML Nasal Spray	SY	724df050-5332-4d0a-9a5f-17bf08a547e1	24
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	784a0e98-c2d6-f845-e053-2991aa0ac4b4	7
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	784a0e98-c2d6-f845-e053-2991aa0ac4b4	7
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	784a0e98-c2d6-f845-e053-2991aa0ac4b4	7
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725064	NARCAN 4 MG in 0.1 ML Nasal Spray	PSN	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725064	naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]	SBD	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725064	Narcan 40 MG/ML Nasal Spray	SY	76b5a1ce-e601-457c-ab35-43533bba4394	2
1725059	naloxone HCl 4 MG in 0.1 ML Nasal Spray	PSN	1fc091cf-a492-2750-e063-6294a90a0aa8	1
1725064	NARCAN 4 MG in 0.1 ML Nasal Spray	PSN	1fc091cf-a492-2750-e063-6294a90a0aa8	1
1725064	naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]	SBD	1fc091cf-a492-2750-e063-6294a90a0aa8	1
1725059	naloxone hydrochloride 40 MG/ML Nasal Spray	SCD	1fc091cf-a492-2750-e063-6294a90a0aa8	1
1725059	naloxone HCl 4 MG per 0.1 ML Nasal Spray	SY	1fc091cf-a492-2750-e063-6294a90a0aa8	1
1725064	Narcan 40 MG/ML Nasal Spray	SY	1fc091cf-a492-2750-e063-6294a90a0aa8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69547-353-02	69547035302	2 VIAL, SINGLE-DOSE in 1 PACKAGE (69547-353-02) / .1 mL in 1 VIAL, SINGLE-DOSE	2017-01-24	2026-05-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Narcan	Emergent Devices Inc.	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	24
Narcan	RedPharm Drug	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
NARCAN NALOXONE HCI NASAL SPRAY 4mg/.1mL	HF Acquisition Co LLC, DBA HealthFirst	2023-10-10	HUMAN PRESCRIPTION DRUG LABEL	7
NARCAN	A-S Medication Solutions	2023-09-28	HUMAN PRESCRIPTION DRUG LABEL	28
Narcan	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	2
NARCAN	Lake Erie Medical DBA Quality Care Products LLC	2021-08-26	HUMAN PRESCRIPTION DRUG LABEL	5