Acetaminophen and Codeine Phosphate

Product NDC: 21695-547
11-digit product format: 216950547
Labeler code: 21695
Product ID: 21695-547_2f92c67b-f324-4c4e-89fd-1e0f8af96fba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen and Codeine Phosphate
Dosage form: SOLUTION
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: ANDA087508
Marketing category: ANDA
Marketing start: 1981-08-21
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CODEINE PHOSPHATE
Active strength: 120 mg/5mL; mg/5mL
DEA schedule: CV
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-547		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-547	21695-547-04	I	Inactivated by FDA		2026-08-03

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 · 44 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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`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	21695-547-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-547-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-547-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-547-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-547-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-547-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-547-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-547-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-547-04	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-547-04	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-547-04	`110d247fa046…`	`a55b01930146…`

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
A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, 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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL		RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	ACETAMINOPHEN AND CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087508-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087508-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087508-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087508-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087508-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087508-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087508-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087508-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087508-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087508-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087508-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087508-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087508-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087508-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087508-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087508-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087508-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087508-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087508-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087508-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087508-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087508-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087508-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087508-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087508-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087508-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087508-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087508-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087508-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087508-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087508-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087508-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087508-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087508-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087508-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087508-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
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20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
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23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
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cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-547-04	2019-09-24	C162847	48780-1	934fe258-4bd8-48b1-e053-8cdaa90a720a	2f92c67b-f324-4c4e-89fd-1e0f8af96fba

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-547-04	Acetaminophen and Codeine Phosphate	118 mL in 1 BOTTLE	SOLUTION	118		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-547-04	ML - Milliliter	21695-547	eb580d9b-59f1-461e-9f5c-b7514c11f3f0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Codeine Phosphate	ACTIVE INGREDIENT	GSL05Y1MN6	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Codeine	ACTIVE MOIETY	Q830PW7520	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-547	ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20100907_2f92c67b-f324-4c4e-89fd-1e0f8af96fba.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	Genus Lifesciences Inc.	95a5d638-3072-4c37-a4cd-f8550328e2c6	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508
Acetaminophen and Codeine Phosphate	ACETAMINOPHEN AND CODEINE PHOSPHATE	PAI Holdings, LLC dba PAI Pharma	95ac6875-6b14-4cde-8efb-80704e39b8d8	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087508 application number: ANDA087508

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993755	codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution	PSN	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1
993755	acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution	SCD	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1
993755	acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution	SY	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1
993755	acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution	SY	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1
993755	APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution	SY	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1
993755	codeine phosphate 12 MG / acetaminophen 120 MG per 5 ML Oral Solution	SY	2f92c67b-f324-4c4e-89fd-1e0f8af96fba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-547-04	21695054704	118 mL in 1 BOTTLE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Codeine Phosphate - Rebel Distributors Corp.	Rebel Distributors Corp.	2010-08-31	HUMAN PRESCRIPTION DRUG LABEL	1