FDA.reportPublic FDA data

Dolex Flex

Product NDC
55758-014
11-digit product format
557580014
Labeler code
55758
Product ID
55758-014_4d7a9ecd-d071-a923-e063-6394a90ad412
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Pharmadel LLC
Application
ANDA078682
Marketing category
ANDA
Marketing start
2023-09-01
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-014-02Dolex Flex2 in 1 PACKETCAPSULE, LIQUID FILLED25
55758-014-20Dolex Flex1 in 1 CARTONCAPSULE, LIQUID FILLED15
55758-014-20Dolex Flex20 in 1 BOTTLECAPSULE, LIQUID FILLED205
55758-014-99Dolex Flex50 in 1 CARTONCAPSULE, LIQUID FILLED505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-014DOLEX FLEX (IBUPROFEN) CAPSULE, LIQUID FILLED [PHARMADEL LLC]4Current NDC, 4 package rows20250206_0543420d-a250-065d-e063-6294a90a005e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN0543420d-a250-065d-e063-6294a90a005e5
310964ibuprofen 200 MG Oral CapsuleSCD0543420d-a250-065d-e063-6294a90a005e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55758-014-02557580014022 in 1 PACKETHistorical
55758-014-20557580014201 BOTTLE in 1 CARTON (55758-014-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-09-07NoNoCurrent
55758-014-995575800149950 PACKET in 1 CARTON (55758-014-99) / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02) 50 packet2023-11-01NoNoCurrent