Orapaz

Manufacturer: Brisk Pharmaceuticals
Effective date: 2025-02-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:25:44

Label at a glance#

ProductOrapaz

Active ingredientCHLORHEXIDINE GLUCONATE, CEPHALEXIN, IBUPROFEN

Label structure3 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Rx Only

NDC 73614-417-03

ORAPAZ™
Each Pack Contains:
Cephalexin Capsules, USP 500 mg - One 30 ct Bottle
Ibuprofen Tablets, USP 800 mg - One 30 ct Bottle
Chlorhexidine Gluconate Oral Rinse, USP 0.12% - Two 118 ml Bottles

Brisk Pharmaceuticals

DESCRIPTION SECTION

Packaged by:

Unit Dose Solutions Inc.,

Morrisville, NC 27560

Distributed by:

Brisk pharmaceuticals,

Richardson, TX 75081

Keep out of reach of children.

Storage: Store at 20°C to 25°C

(68°F-77°F).

Lot: See the lot number on each

individual bottle inside the pack.

Exp: See the expiration date on each

individual bottle inside the pack.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box

ceph

ibu

chlorhex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
309114	cephalexin 500 MG Oral Capsule	PSN	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	PSN	1
197807	ibuprofen 800 MG Oral Tablet	PSN	1
309114	cephalexin 500 MG Oral Capsule	SCD	1
834127	chlorhexidine gluconate 1.2 MG/ML Mouthwash	SCD	1
197807	ibuprofen 800 MG Oral Tablet	SCD	1
309114	cefalexin (as cefalexin monohydrate) 500 MG Oral Capsule	SY	1
834127	chlorhexidine gluconate 0.12 % Mouthwash	SY	1
834127	chlorhexidine gluconate 0.12 % Oral Rinse	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CEPHALEXIN ANHYDROUS Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
CHLORHEXIDINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73614-201-03	Orapaz	30 in 1 BOTTLE	TABLET, FILM COATED	30	800 mg	1
73614-203-01	Orapaz	118 mL in 1 BOTTLE	SOLUTION	118 mL	1.2 mg in 1mL	1
73614-417-03	Orapaz	1 in 1 CARTON	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73614-201	ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Current NDC	20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip
73614-202	ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Unmatched	20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip
73614-203	ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Current NDC	20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip
73614-417	ORAPAZ (CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE) KIT [BRISK PHARMACEUTICALS]	1	Current NDC, 3 package rows	20250214_2de0b332-58a3-0bb4-e063-6394a90a1a45.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

Orapaz
Cephalexin, Ibuprofen, Chlorhexidine Gluconate
Chlorhexidine Gluconate Oral Rinse
ALCOHOL
GLYCERIN
WATER
FD&C BLUE NO. 1
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE
SACCHARIN SODIUM
PEG-40 SORBITAN DIISOSTEARATE
Cephalexin
TITANIUM DIOXIDE
CEPHALEXIN ANHYDROUS
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
GELATIN, UNSPECIFIED
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
Ibuprofen
STEARIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
STARCH, CORN
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73614-417	73614-417-03
73614-203	73614-203-01
73614-202	73614-202-03
73614-201	73614-201-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB
SACCHARIN SODIUM	SB8ZUX40TY	IACT
PEG-40 SORBITAN DIISOSTEARATE	JL4CCU7I1G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CEPHALEXIN	OBN7UDS42Y	ACTIM
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STEARIC ACID	4ELV7Z65AP	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
PEG-40 SORBITAN DIISOSTEARATE	JL4CCU7I1G	IACT
CHLORHEXIDINE GLUCONATE	MOR84MUD8E	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 2 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075561-001	CHLORHEXIDINE GLUCONATE	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT		2000-11-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A075561-001	AT

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL		2000-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075561-001	CHLORHEXIDINE GLUCONATE	0.12%	SOLUTION / DENTAL	AT	2000-11-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075561-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075561-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075561-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075561-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075561-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075561-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075561-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075561-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075561-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075561-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075561-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075561-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075561-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075561-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075561-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075561-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075561-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075561-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075561-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A075561-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075561-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075561-001	AT	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075561-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075561-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075561-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075561-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075561-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075561-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075561-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075561-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075561-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075561-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075561-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075561-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075561-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075561-001	AT	1	`a50c72e98297…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	Approval date
A202413-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23
A202413-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23
A202413-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23
A202413-004	IBUPROFEN	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202413-001	AB
A202413-002	AB
A202413-003	AB

Observed Orange Book product history#

Product history page 1 of 4 · 143 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202413-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202413-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202413-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	AB	1	`301d65b070ca…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Orapaz	CEPHALEXIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE	Brisk Pharmaceuticals	2de0b332-58a3-0bb4-e063-6394a90a1a45	2025-02-11		Exact identifier ndc (package): 73614-202-03 ndc (package): 73614-417-03 ndc (package): 73614-201-03 ndc (package): 73614-203-01 ndc (product): 73614-417 ndc11 (package): 73614020103 ndc11 (package): 73614020301 ndc11 (package): 73614020203 ndc11 (package): 73614041703 spl id: 2de0b332-58a4-0bb4-e063-6394a90a1a45 spl set id: 2de0b332-58a3-0bb4-e063-6394a90a1a45
Ibuprofen	IBUPROFEN	Brisk Pharmaceuticals	2dcbe4bb-fb24-e827-e063-6394a90acf9f	2025-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 73614-201-03 ndc (product): 73614-201 ndc11 (package): 73614020103
Chlorhexidine Gluconate Oral Rinse	CHLORHEXIDINE GLUCONATE ORAL RINSE	Brisk Pharmaceuticals	2dcc3920-d9ed-bd56-e063-6294a90a0f3e	2025-02-10	Warnings, Adverse reactions	Exact identifier ndc (package): 73614-203-01 ndc (product): 73614-203 ndc11 (package): 73614020301
ClindaCare	CLINDAMYCIN, IBUPROFEN, CHLORHEXIDINE GLUCONATE	Brisk Pharmaceuticals	2df8a89c-38df-c63b-e063-6394a90aaa36	2025-02-10		Exact identifier ndc (package): 73614-201-03 ndc (package): 73614-203-01 ndc11 (package): 73614020103 ndc11 (package): 73614020301

Reported adverse events (FAERS/openFDA)#

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