FDA.reportPublic FDA data

NATUREPLEX

Product NDC
67234-020
11-digit product format
672340020
Labeler code
67234
Product ID
67234-020_f7b0de88-6c36-4eda-a770-f71e688c605e
Type
HUMAN OTC DRUG
Nonproprietary name
(saline)
Dosage form
ENEMA
Route
RECTAL
Labeler
Natureplex, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-01
Substance
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength
7; 19 g/133mL; g/133mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NATUREPLEX
Brand name suffix
Enema
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM7 g/133mL
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM19 g/133mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGR686LBA74, 3980JIH2SW
Rxcui283100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67234-020-012026-01-29C16284748780-149896155-cbc2-586f-e063-e6dba90add90SALINE ENEMA LAXATIVE
67234-020-022026-01-29C16284748780-149896155-cbc2-586f-e063-e6dba90add90SALINE ENEMA LAXATIVE
67234-020-032026-01-29C16284748780-149896155-cbc2-586f-e063-e6dba90add90SALINE ENEMA LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-020-01NATUREPLEXEnema133 mL in 1 BOTTLE, WITH APPLICATORENEMA13315
67234-020-01NATUREPLEXEnema1 in 1 CARTONENEMA115
67234-020-02NATUREPLEXEnema2 in 1 CARTONENEMA215
67234-020-02NATUREPLEXEnema133 mL in 1 BOTTLE, WITH APPLICATORENEMA13315
67234-020-03NATUREPLEXEnema3 in 1 CARTONENEMA315
67234-020-03NATUREPLEXEnema133 mL in 1 BOTTLE, WITH APPLICATORENEMA13315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67234-020-01ML - Milliliter67234-020d1cbf942-750b-4770-9bc7-02151df4175812016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM PHOSPHATE, DIBASICACTIVE INGREDIENTGR686LBA74NATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11
SODIUM PHOSPHATE, MONOBASICACTIVE INGREDIENT3980JIH2SWNATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11
SODIUMACTIVE MOIETY9NEZ333N27NATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KNATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11
WATERINACTIVE INGREDIENT059QF0KO0RNATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-020NATUREPLEX ENEMA ((SALINE) ) ENEMA [NATUREPLEX, LLC]14Current NDC, Legacy NDC, 6 package rows20250101_0bd6d0a8-33e5-40be-a6c6-33fea92b11dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML EnemaPSN0bd6d0a8-33e5-40be-a6c6-33fea92b11dd15
283100sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML EnemaSCD0bd6d0a8-33e5-40be-a6c6-33fea92b11dd15
283100sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML EnemaSY0bd6d0a8-33e5-40be-a6c6-33fea92b11dd15
283100sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML EnemaSY0bd6d0a8-33e5-40be-a6c6-33fea92b11dd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67234-020-01672340020011 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-01) / 133 mL in 1 BOTTLE, WITH APPLICATOR2010-06-010000-00-00NoNoCurrent
67234-020-02672340020022 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-02) > 133 mL in 1 BOTTLE, WITH APPLICATOR2010-06-010000-00-00NoNoCurrent
67234-020-03672340020033 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-020-03) > 133 mL in 1 BOTTLE, WITH APPLICATOR2010-06-010000-00-00NoNoCurrent