FDA.reportPublic FDA data

Dolex Fem

Product NDC
55758-326
11-digit product format
557580326
Labeler code
55758
Product ID
55758-326_4a169436-bb76-aceb-e063-6394a90a557f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Caffeine, Pyrilamine Maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Pharmadel LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-01
Substance
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength
500; 60; 15 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55758-32655758-326-02DDiscontinued by firm2026-10-23
excluded packagepackage55758-32655758-326-50DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0555758-326-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0555758-326-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2655758-326-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2655758-326-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3155758-326-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3155758-326-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2855758-326-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2855758-326-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2155758-326-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2155758-326-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1055758-326-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1055758-326-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3155758-326-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3155758-326-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2055758-326-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2055758-326-02ed331223b511…672a5bd82f5f…

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
Dolex Fem
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE60 mg/1
PYRILAMINE MALEATE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1597298Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1cab10b-19f1-f5d5-e053-2995a90a4d5fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
55758-326-022025-07-31Dolex Fem (Health Pharma)
55758-326-022025-07-31Dolex Fem (HHH)
55758-326-252025-07-31Dolex Fem (Health Pharma)
55758-326-252025-07-31Dolex Fem (HHH)
55758-326-502025-07-31Dolex Fem (Health Pharma)
55758-326-502025-07-31Dolex Fem (HHH)
55758-326-022025-07-29Dolex Fem (Health Pharma)
55758-326-022025-07-29Dolex Fem (HHH)
55758-326-252025-07-29Dolex Fem (Health Pharma)
55758-326-252025-07-29Dolex Fem (HHH)
55758-326-502025-07-29Dolex Fem (Health Pharma)
55758-326-502025-07-29Dolex Fem (HHH)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-326-02Dolex Fem2 in 1 PACKETTABLET, COATED213
55758-326-25Dolex Fem1 in 1 CARTONTABLET, COATED113
55758-326-25Dolex Fem24 in 1 BLISTER PACKTABLET, COATED2413
55758-326-50Dolex Fem25 in 1 BOXTABLET, COATED2513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-326DOLEX FEM (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [PHARMADEL LLC]11Current NDC, Legacy NDC, 4 package rows20250206_b1cab10b-19f1-f5d5-e053-2995a90a4d5f.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 37 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDETopCo Associates LLC3b672ec7-8658-4b43-a79d-094ac8bc69042025-09-29WarningsExact identifier
application number: M013
kirkland signature acetaminophen adult extra strengthACETAMINOPHENCostco Wholesale Companya9979167-1a82-47d7-9602-2865f9bdd6282025-09-27WarningsExact identifier
application number: M013
First Aid Direct Chewable AspirinASPIRINCintas Corpff6960f6-9f55-4f32-9ab5-9187724531e92025-09-25WarningsExact identifier
application number: M013
Bayer Rapid Relief Body PainASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.3fa1ec07-d1a6-226b-e063-6394a90a32132025-09-25WarningsExact identifier
application number: M013
Xpect Chewable AspirinASPIRINCintas Corporationbddce374-1d35-4685-987d-4a4cc99941552025-09-25WarningsExact identifier
application number: M013
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsExact identifier
application number: M013
Xpect Pain Away Extra StrengthACETAMINOPHEN ASPIRIN CAFFEINECintas Corporation1269d069-afaf-4ca5-b369-f74249a348db2025-09-24WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINPreferred Pharmaceuticals Inc.29214eec-860c-43f0-83c6-9ed5a9f530af2025-09-22WarningsExact identifier
application number: M013
ASPIRINASPIRINKroger Companybbee8ee4-e09d-3ba6-e053-2a95a90af6472025-09-19WarningsExact identifier
application number: M013
careone acetaminophenACETAMINOPHENAmerican Sales Company4bb696f6-a47b-4da9-9224-9aeae3e152f32025-09-19WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC49a740ec-8ed4-4c76-b2d0-c13651bafa5e2025-09-18WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINEAdvanced Rx LLCa7ed4c76-a5b5-44f7-866f-f43790e45c782025-09-18WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENCVS Pharmacyfc2d4367-8884-4b76-aa3e-8c35be1ace492025-09-18WarningsExact identifier
application number: M013
Aspirin Enteric Coated, Regular StrengthASPIRINWalgreen Company5e1484d3-5be1-40da-a3bf-fb19f7d27d452025-09-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCab02080a-c903-4e4a-a9f3-2b8197ed2f2b2025-09-17WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC79669930-f744-4bb1-8325-b75951489b642025-09-17WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ff199db8-c7ea-4b6e-ad8b-3ceeca883d922025-09-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLFOODHOLD U.S.A., LLCfdd7ce80-d6be-41b9-affd-d024cf306b502025-09-12WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.3e89240b-0e27-fde4-e063-6394a90a779f2025-09-11WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINHEB926fe7b6-9607-469f-912f-4019891067a92025-09-10WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletPSNb1cab10b-19f1-f5d5-e053-2995a90a4d5f13
1597298acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral TabletSCDb1cab10b-19f1-f5d5-e053-2995a90a4d5f13
1597298APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral TabletSYb1cab10b-19f1-f5d5-e053-2995a90a4d5f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-326-02557580326022 in 1 PACKETHistorical
55758-326-24557580326241 BOTTLE in 1 CARTON (55758-326-24) > 24 TABLET, COATED in 1 BOTTLE1 bottle2020-10-010000-00-00NoNoCurrent
55758-326-25557580326251 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK1 blister pack2020-10-010000-00-00NoNoCurrent
55758-326-505575803265025 in 1 BOXHistorical