Cotton Linters

Product NDC: 49288-0154
11-digit product format: 492880154
Labeler code: 49288
Product ID: 49288-0154_3af4be6b-c022-4834-9006-f6cc8d8041da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cotton Linters
Dosage form: INJECTION, SOLUTION
Route: INTRADERMAL; SUBCUTANEOUS
Labeler: Antigen Laboratories, Inc.
Application: BLA102223
Marketing category: BLA
Marketing start: 1974-03-23
Marketing end: 0000-00-00
Substance: COTTON FIBER
Active strength: 0 g/mL
Pharmacologic classes: Non-Standardized Plant Fiber Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Plant Proteins [CS],Allergens [CS]
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49288-0154		I	Inactivated by FDA	2026-08-17
excluded package	package	49288-0154	49288-0154-1	I	Inactivated by FDA	2026-08-17
excluded package	package	49288-0154	49288-0154-2	I	Inactivated by FDA	2026-08-17
excluded package	package	49288-0154	49288-0154-3	I	Inactivated by FDA	2026-08-17
excluded package	package	49288-0154	49288-0154-4	I	Inactivated by FDA	2026-08-17
excluded package	package	49288-0154	49288-0154-5	I	Inactivated by FDA	2026-08-17

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 3 · 132 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	49288-0154-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49288-0154-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49288-0154-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49288-0154-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49288-0154-2	`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	49288-0154-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49288-0154-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49288-0154-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49288-0154-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49288-0154-2	`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	49288-0154-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49288-0154-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49288-0154-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49288-0154-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49288-0154-2	`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	49288-0154-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49288-0154-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49288-0154-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49288-0154-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49288-0154-2	`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	49288-0154-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49288-0154-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49288-0154-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49288-0154-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49288-0154-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49288-0154-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49288-0154-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49288-0154-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49288-0154-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49288-0154-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49288-0154-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49288-0154-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49288-0154-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49288-0154-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49288-0154-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49288-0154-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49288-0154-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49288-0154-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49288-0154-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49288-0154-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49288-0154-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49288-0154-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49288-0154-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49288-0154-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49288-0154-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49288-0154-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49288-0154-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49288-0154-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49288-0154-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49288-0154-2	`ad56d346431e…`	`cc804d4bbf1e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
49288-0154-1	Allergenic Extract
49288-0154-2	Allergenic Extract
49288-0154-3	Allergenic Extract
49288-0154-4	Allergenic Extract
49288-0154-5	Allergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49288-0154-1	Cotton Linters	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	2
49288-0154-2	Cotton Linters	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	2
49288-0154-3	Cotton Linters	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	2
49288-0154-4	Cotton Linters	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	2
49288-0154-5	Cotton Linters	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEIBA PENTANDRA FIBER	ACTIVE INGREDIENT	758Z9H9WV9	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
CORCORUS CAPSULARIS FIBER	ACTIVE INGREDIENT	TVA75O7S63	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
COTTON FIBER	ACTIVE INGREDIENT	70LDW53ROO	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
IRIS GERMANICA VAR. FLORENTINA ROOT	ACTIVE INGREDIENT	M30XO5X4XD	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
PYRETHRUM CINERARIIFOLIUM	ACTIVE INGREDIENT	CGF76TP7X6	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
TOBACCO LEAF	ACTIVE INGREDIENT	6YR2608RSU	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
CEIBA PENTANDRA FIBER	ACTIVE MOIETY	758Z9H9WV9	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
CORCORUS CAPSULARIS FIBER	ACTIVE MOIETY	TVA75O7S63	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
COTTON FIBER	ACTIVE MOIETY	70LDW53ROO	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
IRIS GERMANICA VAR. FLORENTINA ROOT	ACTIVE MOIETY	M30XO5X4XD	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
PYRETHRUM CINERARIIFOLIUM	ACTIVE MOIETY	CGF76TP7X6	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
TOBACCO LEAF	ACTIVE MOIETY	6YR2608RSU	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49288-0154	COTTON LINTERS (Cotton Linters) [Antigen Laboratories, Inc.]	2	Legacy NDC, 5 package rows	20091119_d71013ab-718c-4cb0-ae1a-31fdd6db8851.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
70LDW53ROO	COTTON FIBER	COTTON FIBER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966928	cotton fiber allergenic extract 50 MG/ML Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1014199	jute fiber allergenic extract 50 MG/mL Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
904965	kapok tree fiber allergenic extract 50 MG/mL Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852547	orris root allergenic extract 100 MG/ML Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1098356	orris root allergenic extract 50 MG/ML Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
967973	Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852065	tobacco leaf allergenic extract 100 MG/mL Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
968497	tobacco leaf allergenic extract 20 MG/mL Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
889598	tobacco leaf allergenic extract 50 MG/mL Injectable Solution	PSN	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
966928	cotton fiber allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1014199	jute fiber allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
904965	kapok tree fiber allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852547	orris root allergenic extract 100 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1098356	orris root allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
967973	Pyrethrum cinerariifolium allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852065	tobacco leaf allergenic extract 100 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
968497	tobacco leaf allergenic extract 20 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
889598	tobacco leaf allergenic extract 50 MG/ML Injectable Solution	SCD	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
904965	Ceiba pentandra fiber allergenic extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1014199	Corcorus capsularis fiber extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1014199	Corcorus capsularis fiber extract 50 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
966928	cotton fiber allergenic extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
966928	cotton fiber extract 50 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1098356	Iris germanica var. florentina root allergenic extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1098356	Iris germanica var. florentina root allergenic extract 1 GM per 20 ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852547	Iris germanica var. florentina root extract 0.1 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
1098356	Iris germanica var. florentina root extract 50 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
904965	kapok tree fiber extract 5 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
968497	Nicotiana tabacum leaf extract 0.02 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
889598	Nicotiana tabacum leaf extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852065	Nicotiana tabacum leaf extract 0.1 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852065	Nicotiana tabacum leaf extract 100 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
968497	Nicotiana tabacum leaf extract 20 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
889598	Nicotiana tabacum leaf extract 50 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852547	orris root extract 0.1 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
852547	orris root extract 100 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
967973	Pyrethrum cinerariifolium extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
967973	Tanacetum cinerariifolium extract 0.05 GM/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2
967973	Tanacetum cinerariifolium extract 50 MG/ML Injectable Solution	SY	d71013ab-718c-4cb0-ae1a-31fdd6db8851	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
49288-0154-1	49288015401	2 mL in 1 VIAL, MULTI-DOSE	2 ml	Historical
49288-0154-2	49288015402	5 mL in 1 VIAL, MULTI-DOSE	5 ml	Historical
49288-0154-3	49288015403	10 mL in 1 VIAL, MULTI-DOSE	10 ml	Historical
49288-0154-4	49288015404	30 mL in 1 VIAL, MULTI-DOSE	30 ml	Historical
49288-0154-5	49288015405	50 mL in 1 VIAL, MULTI-DOSE	50 ml	Historical