Rolaids

Product NDC: 84126-367
Requested package NDC: 84126-367-25
11-digit product format: 841260367
Labeler code: 84126
Product ID: 84126-367_5cdacc73-b6b5-b5b8-e063-6294a90a6355
Type: HUMAN OTC DRUG
Nonproprietary name: Famotitine
Dosage form: TABLET
Route: ORAL
Labeler: The Procter & Gamble Manufacturing Company
Application: ANDA077351
Marketing category: ANDA
Marketing start: 2025-09-01
Substance: FAMOTIDINE
Active strength: 20 mg/1
Pharmacologic classes: Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A077351-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2006-09-25

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`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: Rolaids
Brand name suffix: ACID DEFENSE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FAMOTIDINE	20 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcae	Product name	7	20260317
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
cf645750-2e70-f6e1-c05a-a52847def5dd	Product name	9	20250312
4fdc761c-585e-054b-8ebe-86130a26e4c1	Product name	2	20221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84126-367-25	RolaidsACID DEFENSE	1 in 1 CARTON	TABLET	1		3
84126-367-25	RolaidsACID DEFENSE	25 in 1 BOTTLE, PLASTIC	TABLET	25		3

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
heartburn prevention	FAMOTIDINE	Kroger Company	c97851ef-7b49-4f6c-b165-147555db101a	2026-08-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
ACID REDUCER	FAMOTIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f347f870-1da4-4a77-8c20-63b703d24071	2026-08-05	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	8c6d5419-088b-4b3e-80b8-2a0d06926ff1	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
ACID REDUCER	FAMOTIDINE	HyVee Inc	381db08e-5756-4255-8202-1d8e6a1cf038	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	34034d16-dc3b-436d-8ec8-84b3c1f8e48a	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
CareOne Acid Relief	FAMOTIDINE	American Sales Company	206f5483-7de1-4bc3-af27-190e211bcb95	2026-05-21	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Good Sense Acid Reducer	FAMOTIDINE	L. Perrigo Company	39cb0f15-d177-46eb-a549-7acb885fbf07	2026-05-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Acid Controller	FAMOTIDINE	Walgreen Company	42392cb1-7958-4a2f-8622-f00f02afd961	2026-04-24	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid controller	FAMOTIDINE	CVS Pharmacy	1531aa51-02e9-45ed-99aa-53b21732dd2e	2026-04-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Rolaids ACID DEFENSE	FAMOTITINE	The Procter & Gamble Manufacturing Company	3bdbeabb-6b06-5468-e063-6394a90a03c9	2026-03-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351 ndc (package): 84126-367-25 ndc (product): 84126-367 ndc11 (package): 84126036725
ACID REDUCER	FAMOTIDINE	Publix Super Markets Inc	3455be3c-696e-402a-a5df-830544fa525a	2026-03-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Equate Famotidine	FAMOTIDINE	Wal-Mart Stores Inc	8ac94821-aa78-4e57-bc9a-f1f2a0e47b07	2026-03-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid controller	FAMOTIDINE	Walgreen Company	c16d9977-39ad-4386-8867-72aab97c99d5	2026-02-28	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
berkley and jensen famotidine	FAMOTIDINE	BJWC	93c857e4-72b3-433e-ae6f-281cd57e3996	2026-02-17	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid reducer	FAMOTIDINE	H E B	140f0e60-c809-4d86-a750-7649ee2881b5	2026-02-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	45789b7a-e9c7-4813-b07b-f88d9108455d	2026-01-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
careone acid relief	FAMOTIDINE	Retail Business Services, LLC	8f654234-b25d-47d6-b1f8-f7f353569795	2025-10-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Acid Controller	FAMOTIDINE	H E B	8aac5a0d-074b-4cf4-ab10-549e1ed09e2f	2025-10-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	f40f1dcf-249a-4ccb-bdfc-acff49dd4a15	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
basic care heartburn prevention	FAMOTIDINE	Amazon.com Services LLC	8d57f6db-a9f0-4416-9f49-17ce3571b0aa	2025-09-04	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310273	famotidine 20 MG Oral Tablet	PSN	3bdbeabb-6b06-5468-e063-6394a90a03c9	3
310273	famotidine 20 MG Oral Tablet	SCD	3bdbeabb-6b06-5468-e063-6394a90a03c9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84126-367-25	84126036725	1 BOTTLE, PLASTIC in 1 CARTON (84126-367-25) / 25 TABLET in 1 BOTTLE, PLASTIC	2025-09-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rolaids ACID DEFENSE	The Procter & Gamble Manufacturing Company	2026-10-02	HUMAN OTC DRUG LABEL	4