Sarna

Product NDC
0316-0230
11-digit product format
003160230
Labeler code
0316
Product ID
0316-0230_48341fc1-10ea-47fa-e063-6394a90abe32
Type
HUMAN OTC DRUG
Nonproprietary name
Pramoxine Hydrochloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
PRAMOXINE HYDROCHLORIDE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sarna
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii88AYB867L5
Rxcui1246075

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0230-752023-02-13C16284748780-1f386c64a-0288-0266-e053-dadaa90a7c1aSarna Sensitive
0316-0230-752023-01-30C16284748780-1f386c64a-0288-0266-e053-dadaa90a7c1aSarna Sensitive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0230-12Sarna355 mL in 1 BOTTLE, PUMPLOTION3555
0316-0230-25Sarna5 mL in 1 PACKETLOTION55
0316-0230-57Sarna222 mL in 1 BOTTLE, PUMPLOTION2225

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0230-75ML - Milliliter0316-0230c47fd8d6-cdae-4078-8f6f-5cdc699dcd3b12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0230SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES]20Current NDC, Legacy NDC20240602_7b2ff573-ca59-d69a-e053-2a91aa0abcec.zip
0316-0230SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [CROWN LABORATORIES]2Current NDC, Legacy NDC, 3 package rows20250323_19b0ce1b-e147-01a1-e063-6394a90af808.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1246075pramoxine HCl 1 % Topical LotionPSN19b0ce1b-e147-01a1-e063-6394a90af8085
1246075pramoxine hydrochloride 10 MG/ML Topical LotionSCD19b0ce1b-e147-01a1-e063-6394a90af8085
1246075pramoxine hydrochloride 1 % Topical LotionSY19b0ce1b-e147-01a1-e063-6394a90af8085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0230-1200316023012355 mL in 1 BOTTLE, PUMP (0316-0230-12) 355 ml2024-01-01NoNoCurrent
0316-0230-25003160230255 mL in 1 PACKET (0316-0230-25) 5 ml2024-03-18YesNoCurrent
0316-0230-5700316023057222 mL in 1 BOTTLE, PUMP (0316-0230-57) 222 ml2024-01-01NoNoCurrent
0316-0230-7500316023075222 mL in 1 BOTTLE, PUMP (0316-0230-75) 222 ml2018-12-010000-00-00NoNoCurrent