Renacidin

Product NDC: 0327-0012
11-digit product format: 003270012
Labeler code: 0327
Product ID: 0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: citric acid, gluconolactone and magnesium carbonate
Dosage form: SOLUTION
Route: IRRIGATION
Labeler: United-Guardian, Inc.
Application: NDA019481
Marketing category: NDA
Marketing start: 2016-02-01
Substance: ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
Active strength: 6.602; .198; 3.268 g/100mL; g/100mL; g/100mL
Pharmacologic classes: Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Irrigation [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 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
N019481-001	RENACIDIN	CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION		RLD, RS	1990-10-02

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019481-001	RENACIDIN	6.602GM/100ML;198MG/100ML;3.177GM/100ML	SOLUTION / IRRIGATION	RLD, RS	1990-10-02	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ANHYDROUS CITRIC ACID	6.602 g/100mL
GLUCONOLACTONE	.198 g/100mL
MAGNESIUM CARBONATE	3.268 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XF417D3PSL	Internal UNII lookup
WQ29KQ9POT	Internal UNII lookup
0E53J927NA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1792396	Internal RxNorm lookup
1792398	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
13a9bbba-db21-4cba-991c-5d8afaf2ed74	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0327-0012-30	Renacidin	30 in 1 CARTON	SOLUTION	30		3
0327-0012-30	Renacidin	30 mL in 1 BOTTLE	SOLUTION	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0327-0012-30	ML - Milliliter	0327-0012	9a758ea9-cc27-4784-bf08-a37ed710593d	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0327-0012	RENACIDIN (CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE) SOLUTION [UNITED-GUARDIAN, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20191231_13a9bbba-db21-4cba-991c-5d8afaf2ed74.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
Renacidin	CITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATE	United-Guardian, Inc.	13a9bbba-db21-4cba-991c-5d8afaf2ed74	2019-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019481 application number: NDA019481 ndc (product): 0327-0012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XF417D3PSL	ANHYDROUS CITRIC ACID	77-92-9	ANHYDROUS CITRIC ACID
WQ29KQ9POT	GLUCONOLACTONE	90-80-2	GLUCONOLACTONE
0E53J927NA	MAGNESIUM CARBONATE	17968-26-2	MAGNESIUM CARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1792396	citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG in 30 ML Irrigation Solution	PSN	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792398	RENACIDIN 1980.6 MG / 59.4 MG / 980.4 MG in 30 ML Irrigation Solution	PSN	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792398	citric acid 66 MG/ML / gluconolactone 1.98 MG/ML / magnesium carbonate 32.7 MG/ML Irrigation Solution [Renacidin]	SBD	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792396	citric acid 66 MG/ML / gluconolactone 1.98 MG/ML / magnesium carbonate 32.7 MG/ML Irrigation Solution	SCD	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792396	citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG per 30 ML Irrigation Solution	SY	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792396	citric acid 6.602 GM / gluconolactone 0.198 GM / magnesium carbonate 3.268 GM per 100 ML Irrigation Solution	SY	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3
1792398	Renacidin (citric acid 1980.6 MG / gluconolactone 59.4 MG / magnesium carbonate 980.4 MG) per 30 ML Irrigation Solution	SY	13a9bbba-db21-4cba-991c-5d8afaf2ed74	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0327-0012-30	00327001230	30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE	30 bottle	2016-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Renacidin ® (Citric Acid, Glucono Delta-Lactone, and Magnesium Carbonate) Irrigation Solution	United-Guardian, Inc.	2019-12-17	HUMAN PRESCRIPTION DRUG LABEL	3