Midol

Product NDC: 67751-145
11-digit product format: 677510145
Labeler code: 67751
Product ID: 67751-145_4efb2a06-f0fb-b6d2-e063-6294a90a92d4
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: Navajo Manufacturing Company Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-09-19
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	67751-145		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-145	67751-145-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67751-145	67751-145-02	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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: Midol
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
cabd10f2-a91e-4406-9249-915e306c867b	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
67751-145-01	2024-04-15	Midol
67751-145-02	2024-04-15	Midol
67751-145-01	2024-01-30	Midol
67751-145-02	2024-01-30	Midol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-145-01	Midol	2 in 1 CARTON	TABLET	2	7
67751-145-01	Midol	2 in 1 POUCH	TABLET	2	7
67751-145-02	Midol	2 in 1 CARTON	TABLET	2	7
67751-145-02	Midol	4 in 1 POUCH	TABLET	4	7
67751-145-06	Midol	2 in 1 POUCH	TABLET	2	7
67751-145-06	Midol	3 in 1 CARTON	TABLET	3	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-145	MIDOL (ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]	6	Current NDC, Legacy NDC, 6 package rows	20241004_cabd10f2-a91e-4406-9249-915e306c867b.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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6fee238-0b6f-cb84-e053-2995a90a361b	2024-12-05	Warnings	Exact identifier application number: M013
Menstrual Complete Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	L.N.K. International, Inc.	379ef03c-3b6a-40c3-b736-99f0537d26c8	2024-12-05	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Marc Glassman, Inc.	43bf297f-2832-424f-a013-4bfa1d6c03e6	2024-12-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	5a68ab98-720c-479a-a60a-4e594add6c09	2024-12-04	Warnings	Exact identifier application number: M013
HEB Effervescent Pain Relief	ASPIRIN	H. E. BUTT GROCERY COMPANY	03876c71-60ec-3280-e063-6294a90a62dc	2024-12-03	Warnings	Exact identifier application number: M013
Migrafein FORTE	ACETAMINOPHEN, CAFFEINE	OPMX LLC	028875c9-4129-ce2c-e063-6294a90a26cc	2024-12-03	Warnings	Exact identifier application number: M013
Neo-Lubrina Fuerte	ACETAMINOPHEN, CAFFEINE	OPMX LLC	0288a327-fd4b-1991-e063-6294a90ace50	2024-12-03	Warnings	Exact identifier application number: M013
CAFIZETAMOL FORTE	ACETAMINOPHEN, CAFFEINE	OPMX LLC	028771d3-a514-f7a5-e063-6394a90ac4f3	2024-12-03	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	048c4b03-1cf4-b724-e063-6294a90a1cad	2024-12-03	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	TopCo Associates LLC	ecd6df7e-e7e2-446b-85ef-25971281fe31	2024-12-03	Warnings	Exact identifier application number: M013
Market Basket Effervescent Pain Relief	ASPIRIN	DEMOULAS SUPER MARKETS, INC.	08133bf0-3c8f-e4d0-e063-6294a90af79a	2024-12-03	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	WinCo Foods, LLC	4359da13-e851-440b-91b9-6b544bff20d2	2024-12-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	WinCo Foods, LLC	5b3e8a78-5357-42ad-811e-b2578b25dc7b	2024-12-03	Warnings	Exact identifier application number: M013
Low Strength Chewable Aspirin	ASPIRIN	Geri-Care Pharmaceutical Corp	cc77b9d1-7874-4ce8-a763-3a0e1c2891de	2024-12-03	Warnings	Exact identifier application number: M013
Good Sense Childrens Pain and Fever	ACETAMINOPHEN	L. Perrigo Company	c6b79501-d08b-4430-9545-70da5f545975	2024-12-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association	0e3be5f4-bc1b-4b44-a86a-ace89f6ee592	2024-12-02	Warnings	Exact identifier application number: M013
St. Joseph Chewable Low Dose Aspirin	ASPIRIN	Foundation Consumer Healthcare LLC	248cd302-e380-4837-bdae-9df620b67e8a	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	2d98e390-4f2a-41cc-b307-3d2f6a3700dd	2024-12-02	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	409b5fcd-5880-4dda-85d8-26aeceb4f8ab	2024-12-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	AAA Pharmaceutical, Inc.	c0c31523-c4c5-43c2-8d72-4d1456c720e9	2024-12-02	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	cabd10f2-a91e-4406-9249-915e306c867b	7
1597298	acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet	SCD	cabd10f2-a91e-4406-9249-915e306c867b	7
1597298	APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet	SY	cabd10f2-a91e-4406-9249-915e306c867b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67751-145-01	67751014501	2 POUCH in 1 CARTON (67751-145-01) / 2 TABLET in 1 POUCH	2 pouch	2016-09-19	0000-00-00	No	No	Current
67751-145-02	67751014502	2 POUCH in 1 CARTON (67751-145-02) / 4 TABLET in 1 POUCH	2 pouch	2016-09-19	0000-00-00	No	No	Current
67751-145-06	67751014506	3 POUCH in 1 CARTON (67751-145-06) / 2 TABLET in 1 POUCH	3 pouch	2025-05-09		No	No	Current