Zegerid OTC

Product NDC: 82632-100
11-digit product format: 826320100
Labeler code: 82632
Product ID: 82632-100_7e277414-7482-4bfc-935b-aee179357434
Type: HUMAN OTC DRUG
Nonproprietary name: Omeprazole, Sodium Bicarbonate
Dosage form: CAPSULE
Route: ORAL
Labeler: Riley Consumer Care LLC
Application: NDA022281
Marketing category: NDA
Marketing start: 2024-03-01
Substance: OMEPRAZOLE; SODIUM BICARBONATE
Active strength: 20; 1100 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N022281-001	ZEGERID OTC	OMEPRAZOLE; SODIUM BICARBONATE	20MG;1.1GM	CAPSULE / ORAL		RLD, RS	2009-12-01

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022281-001	ZEGERID OTC	20MG;1.1GM	CAPSULE / ORAL	RLD, RS	2009-12-01	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Zegerid OTC
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1
SODIUM BICARBONATE	1100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup
8MDF5V39QO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616539	Internal RxNorm lookup
646344	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82632-100-01	Zegerid OTC	1 in 1 CARTON	CAPSULE	1	3
82632-100-01	Zegerid OTC	14 in 1 BOTTLE	CAPSULE	14	3
82632-100-03	Zegerid OTC	42 in 1 BOTTLE	CAPSULE	42	3
82632-100-03	Zegerid OTC	1 in 1 CARTON	CAPSULE	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82632-100	ZEGERID OTC (OMEPRAZOLE, SODIUM BICARBONATE) CAPSULE [RILEY CONSUMER CARE LLC]	1	Current NDC, 4 package rows	20240301_1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zegerid OTC	OMEPRAZOLE, SODIUM BICARBONATE	Riley Consumer Care LLC	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	2025-12-24	Warnings	Exact identifier application applno (NDA): 022281 application number: NDA022281 ndc (product): 82632-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	PSN	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
646344	Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006	PSN	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
646344	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SBD	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
616539	omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule	SCD	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
616539	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule	SY	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
646344	Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]	SY	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
646344	Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006	SY	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3
646344	Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule	SY	1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82632-100-01	82632010001	1 BOTTLE in 1 CARTON (82632-100-01) / 14 CAPSULE in 1 BOTTLE	1 bottle	2024-03-01	No	No	Current
82632-100-03	82632010003	1 BOTTLE in 1 CARTON (82632-100-03) / 42 CAPSULE in 1 BOTTLE	1 bottle	2024-03-01	No	No	Current