TYLENOL with Codeine

Product NDC: 50458-515
11-digit product format: 504580515
Labeler code: 50458
Product ID: 50458-515_44171662-6387-11ea-b4d5-18e4fb2ca371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetaminophen and codeine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Janssen Pharmaceuticals, Inc.
Application: ANDA085055
Marketing category: ANDA
Marketing start: 1977-08-17
Marketing end: 2021-01-11
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 300 mg/1; mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50458-515		D	Discontinued by firm	2026-08-07
excluded package	package	50458-515	50458-515-60	D	Discontinued by firm	2026-08-07
excluded package	package	50458-515	50458-515-70	D	Discontinued by firm	2026-08-07

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 1 · 36 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	50458-515-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50458-515-70	`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	50458-515-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50458-515-70	`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	50458-515-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50458-515-70	`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	50458-515-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50458-515-70	`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	50458-515-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50458-515-70	`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	50458-515-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50458-515-70	`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	50458-515-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50458-515-70	`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	50458-515-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50458-515-70	`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	50458-515-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50458-515-70	`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	50458-515-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50458-515-70	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50458-515-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50458-515-70	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50458-515-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50458-515-70	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A085055-001	TYLENOL W/ CODEINE NO. 1	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;7.5MG	TABLET / ORAL	Approved before 1982
A085055-002	TYLENOL W/ CODEINE NO. 2	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982
A085055-003	TYLENOL W/ CODEINE NO. 3	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982
A085055-004	TYLENOL W/ CODEINE NO. 4	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET / ORAL	RLD, 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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085055-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085055-004	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A085055-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A085055-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085055-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A085055-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085055-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A085055-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085055-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A085055-004	AA	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-515-60	EA - Each	50458-515	94e9be77-4292-4efa-a22b-846075832f68	1	2012-07-24
50458-515-70	EA - Each	50458-515	718a5443-1242-45bd-bf8f-f6f5cc5bc719	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
codeine phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
acetaminophen	ACTIVE MOIETY	362O9ITL9D	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
codeine anhydrous	ACTIVE MOIETY	UX6OWY2V7J	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
powdered cellulose	INACTIVE INGREDIENT	SMD1X3XO9M	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
sodium metabisulfite	INACTIVE INGREDIENT	4VON5FNS3C	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	TYLENOL WITH CODEINE (ACETAMINOPHEN AND CODEINE PHOSPHATE) TABLET [JANSSEN PHARMACEUTICALS, INC.]	9

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
GSL05Y1MN6	CODEINE PHOSPHATE	41444-62-6	CODEINE PHOSPHATE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TYLENOL ® with Codeine CIII (acetaminophen and codeine phosphate) tablets	Janssen Pharmaceuticals, Inc. \| Janssen Ortho LLC \| Mallinckrodt Inc. \| Noramco Inc. \| Ortho-McNeil-Janssen Pharmaceuticals, Inc.	2020-12-15	HUMAN PRESCRIPTION DRUG LABEL	20