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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55758-326	55758-326-02	D	Discontinued by firm		2026-10-23
excluded package	package	55758-326	55758-326-50	D	Discontinued by firm		2026-10-23

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	55758-326-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	55758-326-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	55758-326-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	55758-326-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	55758-326-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	55758-326-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	55758-326-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	55758-326-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	55758-326-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	55758-326-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	55758-326-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	55758-326-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	55758-326-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	55758-326-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	55758-326-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	55758-326-02	`ed331223b511…`	`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
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
CAFFEINE	60 mg/1
PYRILAMINE MALEATE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
3G6A5W338E	Internal UNII lookup
R35D29L3ZA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b1cab10b-19f1-f5d5-e053-2995a90a4d5f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
55758-326-02	2025-07-31	Dolex Fem (Health Pharma)
55758-326-02	2025-07-31	Dolex Fem (HHH)
55758-326-25	2025-07-31	Dolex Fem (Health Pharma)
55758-326-25	2025-07-31	Dolex Fem (HHH)
55758-326-50	2025-07-31	Dolex Fem (Health Pharma)
55758-326-50	2025-07-31	Dolex Fem (HHH)
55758-326-02	2025-07-29	Dolex Fem (Health Pharma)
55758-326-02	2025-07-29	Dolex Fem (HHH)
55758-326-25	2025-07-29	Dolex Fem (Health Pharma)
55758-326-25	2025-07-29	Dolex Fem (HHH)
55758-326-50	2025-07-29	Dolex Fem (Health Pharma)
55758-326-50	2025-07-29	Dolex Fem (HHH)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55758-326-02	Dolex Fem	2 in 1 PACKET	TABLET, COATED	2	13
55758-326-25	Dolex Fem	1 in 1 CARTON	TABLET, COATED	1	13
55758-326-25	Dolex Fem	24 in 1 BLISTER PACK	TABLET, COATED	24	13
55758-326-50	Dolex Fem	25 in 1 BOX	TABLET, COATED	25	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-326	DOLEX FEM (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [PHARMADEL LLC]	11	Current NDC, Legacy NDC, 4 package rows	20250206_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 46 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	bdc466c9-d9ae-4293-b7ea-46fb517661c6	2025-04-01	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	e327a52a-0e31-44b7-9823-7f60d070ae52	2025-04-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	9af5ccc8-aac0-4339-a9f6-58fdc9b91c57	2025-04-01	Warnings	Exact identifier application number: M013
ASPIRIN 325 MG EC	ASPIRIN	Bryant Ranch Prepack	9d0449d2-c0c6-4e74-931b-35dc62584028	2025-03-31	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	Bryant Ranch Prepack	cce1e8bd-63c8-403a-bc32-e6788493f604	2025-03-31	Warnings	Exact identifier application number: M013
Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength	ACETAMINOPHEN	Aurex Laboratories Limited Liability Company	948c5826-6f35-484d-bb3f-cecf6a4b5c13	2025-03-31	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREENS	281a530b-c759-50eb-e063-6394a90abb4f	2025-03-28	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WR Group, Inc.	8281771c-485c-42a9-9a1c-9a7a4298c5b8	2025-03-28	Warnings	Exact identifier application number: M013
Acetaminophen Regular strength	ACETAMINOPHEN	PD-Rx Pharmaceuticals, Inc.	4181efc2-d183-410c-b647-233444c57e32	2025-03-20	Warnings	Exact identifier application number: M013
CounterAct Pain	ACETAMINOPHEN	Melaleuca, Inc.	7faf76b4-7f25-377d-e053-2a91aa0a19d4	2025-03-20	Boxed warning, Warnings	Exact identifier application number: M013
Mejoral	ACETAMINOPHEN, CAFFEINE	OPMX LLC	0bccf571-fcb9-2dd5-e063-6294a90a5f16	2025-03-19	Warnings	Exact identifier application number: M013
ARTRIFIN 24 CAPLETS	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e7f15c2b-a730-b54f-e053-2a95a90a3b3e	2025-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	TARGET Corporation	1fc3806e-a5c4-4a6e-951b-dfbf9f5771f1	2025-03-17	Warnings	Exact identifier application number: M013
Signature Select Effervescent Pain Relief	ASPIRIN	Safeway Inc.	304fca65-2867-c963-e063-6394a90a183f	2025-03-14	Warnings	Exact identifier application number: M013
GOOD REMEDIES Extra Strength Pain Relief PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d642d8e-c154-a970-e063-6294a90a03bf	2025-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac4	2025-03-07	Warnings	Exact identifier application number: M013
Redicare Non-Aspirin 500mg	REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG	Redicare LLC	2f229898-1777-732c-e063-6394a90a76bc	2025-03-04	Warnings, Adverse reactions	Exact identifier application number: M013
Major Extra Strength Acetaminophen Liquid	ACETAMINOPHEN	Major Pharmaceuticals	2f3af4dd-45d5-87b4-e063-6294a90ab3cc	2025-02-28	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed9a71d6-a56e-416a-bb89-6d41307efc5a	2025-02-27	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	77429b7f-78e4-42c0-8679-ae8da1748848	2025-02-26	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
R35D29L3ZA	PYRILAMINE MALEATE	59-33-6	PYRILAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1597298	acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet	PSN	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	13
1597298	acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet	SCD	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	13
1597298	APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet	SY	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55758-326-02	55758032602	2 in 1 PACKET						Historical
55758-326-24	55758032624	1 BOTTLE in 1 CARTON (55758-326-24) > 24 TABLET, COATED in 1 BOTTLE	1 bottle	2020-10-01	0000-00-00	No	No	Current
55758-326-25	55758032625	1 BLISTER PACK in 1 CARTON (55758-326-25) / 24 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2020-10-01	0000-00-00	No	No	Current
55758-326-50	55758032650	25 in 1 BOX						Historical