Ibuprofen and Pseudoephedrine Hydrochloride

Product NDC: 63868-453
11-digit product format: 638680453
Labeler code: 63868
Product ID: 63868-453_9b971e5f-98b5-4030-96d0-2b8aa5c03609
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen and Pseudoephedrine Hydrochloride
Dosage form: TABLET, SUGAR COATED
Route: ORAL
Labeler: Chain Drug Marketing Association Inc.
Application: ANDA074567
Marketing category: ANDA
Marketing start: 2001-10-13
Marketing end: 0000-00-00
Substance: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 200 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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	63868-453		I	Inactivated by FDA		2026-08-17
excluded package	package	63868-453	63868-453-20	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 1 · 42 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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`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	63868-453-20	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074567-001	IBUPROHM COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL			2001-04-17

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-453-20	2020-01-31	C162847	48780-1	9d75b9d1-16c8-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-453-20	Ibuprofen and Pseudoephedrine Hydrochloride	20 in 1 BLISTER PACK	TABLET, SUGAR COATED	20		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-453-20	EA - Each	63868-453	18807e03-5d45-416e-90bf-79d792592f80	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
TRISTEARIN	INACTIVE INGREDIENT	P6OCJ2551R	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-453	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2	Legacy NDC, 1 package rows	20121114_093e6388-54f2-4d04-ba55-8f7c9c182a0e.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
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	c0692a21-358d-47b9-bbff-cc8f4f3bdb56	2026-08-05	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN COMPANY	c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0	2026-07-31	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Rite-Aid	483c3bb7-529e-4684-80e1-6646b050988e	2026-07-31	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	2b98a62b-bd92-4fb8-ad0f-521cb477b612	2026-07-31	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	The Kroger Company	2c15339d-a33b-4884-87d8-a3b50903a2c8	2026-07-31	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	627ea7db-47f1-40c2-b1ca-72dc66542e4a	2026-07-31	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	65ec0f85-7ca3-4adc-b152-a0ae2fd0692f	2025-02-27	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	d93ae778-e6e9-4d1d-8f46-c04d962a9393	2024-11-22	Warnings	Exact identifier application applno (ANDA): 074567 application number: ANDA074567

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1299021	ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet	PSN	093e6388-54f2-4d04-ba55-8f7c9c182a0e	2
1299021	ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	093e6388-54f2-4d04-ba55-8f7c9c182a0e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63868-453-20	63868045320	20 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Chain Drug Marketing Association Inc. \| Ranbaxy Pharmaceuticals Inc. \| Ohm Laboratories Inc.	2012-09-12	HUMAN OTC DRUG LABEL	2