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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	BAYER GENUINE ASPIRIN	Lil' Drug Store Products, Inc.	d17834d7-cb3e-6bf2-e053-2a95a90ae5c1	2024-12-30	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fd2b46-683e-4cf5-e053-2995a90a5512	2024-12-30	Warnings	Exact identifier application number: M013
Night Time Severe Cold and Cough Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Chain Drug Consortium, LLC	c8e9b57b-83e9-46c5-9791-02c4c2b94004	2024-12-29	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f6a9ea44-08b8-4a33-bfbd-68cb2d852c39	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	cfc7eac3-35be-4002-b8ef-be1dfc8caf69	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	a3031139-4709-43f2-95a8-89840c595f7f	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	WALGREENS CO.	98bb28ed-d146-ca3d-e053-2a95a90a9eaf	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg	ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG	WALGREENS CO.	982faa74-d498-cd1e-e053-2995a90afa1e	2024-12-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	11bf6e1b-aed9-4f8f-9f03-ea911ae9f702	2024-12-23	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	RUGBY LABORATORIES	295b0d00-4d4a-405f-9325-d01c5d4f3ed4	2024-12-20	Warnings	Exact identifier application number: M013
Walgreens Pain Relief Powder	ASPIRIN AND CAFFEINE	Walgreens Co.	61493d34-2432-4683-9b32-e1851a4337be	2024-12-18	Warnings	Exact identifier application number: M013
Reese Headache Powders	ASPIRIN AND CAFFEINE	Reese Pharmaceutical Co	386f7a6c-4bfc-4140-a67b-07f6b520d58f	2024-12-18	Warnings	Exact identifier application number: M013
NobleAid PAIN RELIEVER	ASPIRIN	Noble Otc LLC	aa08e488-2f69-4d7e-86ba-ccfad563edcf	2024-12-18	Warnings	Exact identifier application number: M013
Dollar General Headache Powders	ASPIRIN AND CAFFEINE	Dolgencorp, LLC	11b0271b-d65c-49c4-a081-d71044a0e04c	2024-12-18	Warnings	Exact identifier application number: M013
Family Wellness Pain Relief Powder	ASPIRIN AND CAFFEINE	Family Dollar Services Inc	b2e55de7-3c36-49cc-8f7f-1013fd1ec359	2024-12-18	Warnings	Exact identifier application number: M013
Best Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Value Merch	a95b9b22-ea5c-4a02-b35d-c8ae1e117604	2024-12-18	Warnings	Exact identifier application number: M013
Walmart Pain Relief Powder	ASPIRIN AND CAFFEINE	Walmart	c69aa61f-6a74-40a3-8737-195fa545e261	2024-12-18	Warnings	Exact identifier application number: M013
Quality Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Chain Drug Marketing Association	8e1f4057-4968-4523-9b3f-55aea421b674	2024-12-18	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