FDA.reportPublic FDA data

Sal De Uvas Picot

Product NDC
67751-174
11-digit product format
677510174
Labeler code
67751
Product ID
67751-174_5d6d144f-d900-b5ad-e063-6294a90aa026
Type
HUMAN OTC DRUG
Nonproprietary name
CITRIC ACID MONOHYDRATE, SODIUM BICARBONATE
Dosage form
GRANULE, EFFERVESCENT
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-23
Marketing end
2027-01-01
Substance
CITRIC ACID MONOHYDRATE; SODIUM BICARBONATE
Active strength
1.9485; 2.485 g/1; g/1
Pharmacologic classes
Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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
Sal De Uvas Picot

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITRIC ACID MONOHYDRATE1.9485 g/1
SODIUM BICARBONATE2.485 g/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-03-16Sal De Uvas Picot
2023-03-16Sal De Uvas Picot
2023-01-30Sal De Uvas Picot
2023-01-30Sal De Uvas Picot

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-174-01Sal De Uvas Picot1 in 1 CARTONGRANULE, EFFERVESCENT14
67751-174-01Sal De Uvas Picot1 in 1 POUCHGRANULE, EFFERVESCENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-174SAL DE UVAS PICOT (CITRIC ACID MONOHYDRATE, SODIUM BICARBONATE) GRANULE, EFFERVESCENT [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 2 package rows20241004_ff6ac79d-564d-4abf-83c7-b01751249c7f.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 34 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e82a4f4-c7da-09cb-e053-2a91aa0abf5b2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEWAL-MART STORES, INC.7cc2ad32-fdff-0772-e053-2a91aa0aad9e2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWAL-MART STORES, INC.7cc2771e-abd7-4120-e053-2a91aa0a8af02023-11-01WarningsExact identifier
application number: M001
MINTOX MAXIMUM STRENGTHALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEProficient Rx LPb7711b50-c14a-44d6-b647-1f31284f87ea2023-11-01WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e811783-cbf6-d0e3-e053-2991aa0ae69f2023-10-31WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS5f880b43-2977-7a2d-e053-2991aa0a024d2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYd5661964-9d2c-7a3d-e053-2995a90a86ef2023-10-31WarningsExact identifier
application number: M001
EXTRA STRENGTH HEARTBURN RELIEFALUMINUM HYDROXIDE AND MAGNESIUM CARBONATECVS PHARMACY,INC.53fc327e-e345-26f2-e054-00144ff8d46c2023-10-31WarningsExact identifier
application number: M001
MAXIMUM STRENGTH ANTACID AND ANTIGAS CHERRYALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEVALU MERCHANDISERS COMPANY5e94cb90-b616-dcfe-e053-2a91aa0ada722023-10-31WarningsExact identifier
application number: M001
CALCIUM CARBONATE CHEWABLE ANTACIDCALCIUM CARBONATEGeri-Care Pharmaceutical Corp27d9b505-08bd-4261-a59d-6ddc4031be322023-10-25WarningsExact identifier
application number: M001
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEAPNAR PHARMA LPe4ef2224-07e4-e913-e053-2995a90a28ed2023-10-21WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd5c123f8-1396-4d8c-96d3-e5ade96a6ef82020-11-10WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEEndo USAd3c5b01b-f0d6-4503-ab18-b1a72386e2c62020-06-03WarningsExact identifier
application number: M001
Magnesium Oxide 400mgMAGNESIUM OXIDE 400MGAllegiant Health2ea68874-8c20-4284-bd0a-f07768057b832019-01-28WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health51dd53e8-22ff-4967-9124-f15c3986e4dd2017-11-17WarningsExact identifier
application number: M001
Calcium AntacidCALCIUM CARBONATEAllegiant Health551d6135-2650-4c27-a20d-d56a9aba7b712017-11-08WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795948citric acid 1.949 GM / sodium bicarbonate 2.485 GM Powder for Oral SolutionPSNff6ac79d-564d-4abf-83c7-b01751249c7f4
1795950picot 1.949 GM / 2.485 GM Powder for Oral SolutionPSNff6ac79d-564d-4abf-83c7-b01751249c7f4
1795950citric acid 1949 MG / sodium bicarbonate 2485 MG Powder for Oral Solution [Picot]SBDff6ac79d-564d-4abf-83c7-b01751249c7f4
1795948citric acid 1949 MG / sodium bicarbonate 2485 MG Powder for Oral SolutionSCDff6ac79d-564d-4abf-83c7-b01751249c7f4
1795948citric acid 1.949 GM / sodium bicarbonate 2.485 GM Powder for Oral SolutionSYff6ac79d-564d-4abf-83c7-b01751249c7f4
1795948Citric Acid 1949 MG / NaHCO3 2485 MG Powder for Oral SolutionSYff6ac79d-564d-4abf-83c7-b01751249c7f4
1795950Citric Acid 1949 MG / NaHCO3 2485 MG Powder for Oral Solution [Picot]SYff6ac79d-564d-4abf-83c7-b01751249c7f4
1795950Picot 1.949 GM / 2.485 GM Powder for Oral SolutionSYff6ac79d-564d-4abf-83c7-b01751249c7f4
1795950sal de uvas picot 1.949 GM / 2.485 GM Powder for Oral SolutionSYff6ac79d-564d-4abf-83c7-b01751249c7f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67751-174-01677510174011 POUCH in 1 CARTON (67751-174-01) / 1 GRANULE, EFFERVESCENT in 1 POUCH1 pouch2016-09-232027-01-01NoNoCurrent