Nitrous Oxide

Product NDC: 48883-004
11-digit product format: 488830004
Labeler code: 48883
Product ID: 48883-004_ef3b5bcc-51d6-4ec8-8f5d-d5b8ff7fbba5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrous Oxide
Dosage form: GAS
Route: RECTAL
Labeler: Encompass Medical & Specialty Gases, Ltd.
Marketing category: UNAPPROVED MEDICAL GAS
Marketing start: 2008-01-02
Marketing end: 0000-00-00
Substance: NITROUS OXIDE
Active strength: 990 mL/L
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	48883-004		I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-06	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-07	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-08	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-09	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-10	I	Inactivated by FDA	2026-10-05
excluded package	package	48883-004	48883-004-11	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 5 · 264 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48883-004-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48883-004-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48883-004-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48883-004-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48883-004-11	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
48883-004-01	Nitrous Oxide Label
48883-004-02	Nitrous Oxide Label
48883-004-03	Nitrous Oxide Label
48883-004-04	Nitrous Oxide Label
48883-004-05	Nitrous Oxide Label
48883-004-06	Nitrous Oxide Label
48883-004-07	Nitrous Oxide Label
48883-004-08	Nitrous Oxide Label
48883-004-09	Nitrous Oxide Label
48883-004-10	Nitrous Oxide Label
48883-004-11	Nitrous Oxide Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
48883-004-01	Nitrous Oxide	148 L in 1 CYLINDER	GAS	148	1
48883-004-02	Nitrous Oxide	936 L in 1 CYLINDER	GAS	936	1
48883-004-03	Nitrous Oxide	991 L in 1 CYLINDER	GAS	991	1
48883-004-04	Nitrous Oxide	1577 L in 1 CYLINDER	GAS	1577	1
48883-004-05	Nitrous Oxide	1726 L in 1 CYLINDER	GAS	1726	1
48883-004-06	Nitrous Oxide	2464 L in 1 CYLINDER	GAS	2464	1
48883-004-07	Nitrous Oxide	4927 L in 1 CYLINDER	GAS	4927	1
48883-004-08	Nitrous Oxide	7386 L in 1 CYLINDER	GAS	7386	1
48883-004-09	Nitrous Oxide	7391 L in 1 CYLINDER	GAS	7391	1
48883-004-10	Nitrous Oxide	12318 L in 1 DEWAR	GAS	12318	1
48883-004-11	Nitrous Oxide	13810 L in 1 DEWAR	GAS	13810	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitrous Oxide	ACTIVE INGREDIENT	K50XQU1029	NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]	1
Nitrous Oxide	ACTIVE MOIETY	K50XQU1029	NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48883-004	NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]	1	Legacy NDC, 11 package rows	20101220_ffcfc7c1-5806-4f37-9a0f-f64cb06410e0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K50XQU1029	NITROUS OXIDE	10024-97-2	NITROUS OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
48883-004-01	48883000401	148 L in 1 CYLINDER	148 l	Historical
48883-004-02	48883000402	936 L in 1 CYLINDER	936 l	Historical
48883-004-03	48883000403	991 L in 1 CYLINDER	991 l	Historical
48883-004-04	48883000404	1577 L in 1 CYLINDER	1577 l	Historical
48883-004-05	48883000405	1726 L in 1 CYLINDER	1726 l	Historical
48883-004-06	48883000406	2464 L in 1 CYLINDER	2464 l	Historical
48883-004-07	48883000407	4927 L in 1 CYLINDER	4927 l	Historical
48883-004-08	48883000408	7386 L in 1 CYLINDER	7386 l	Historical
48883-004-09	48883000409	7391 L in 1 CYLINDER	7391 l	Historical
48883-004-10	48883000410	12318 L in 1 DEWAR	12318 l	Historical
48883-004-11	48883000411	13810 L in 1 DEWAR	13810 l	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrous Oxide Label	Encompass Medical & Specialty Gases, Ltd.	2010-12-03	HUMAN PRESCRIPTION DRUG LABEL	1