M-Dryl

Product NDC: 58657-528
11-digit product format: 586570528
Labeler code: 58657
Product ID: 58657-528_41b56261-e688-a46d-e063-6394a90a9246
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: LIQUID
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-01
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: M-Dryl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049906	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
5a60c923-8bb7-427f-9636-08ed5474f71b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58657-528-04	M-Dryl	120 mL in 1 BOTTLE	LIQUID	120		6
58657-528-16	M-Dryl	473 mL in 1 BOTTLE	LIQUID	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-528-04	ML - Milliliter	58657-528	265ac152-5371-4230-857a-ac050c9efddf	1	2019-09-05
58657-528-16	ML - Milliliter	58657-528	7692d868-6561-46ac-8d17-ec2a9710c2c6	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-528	M-DRYL (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20241126_5a60c923-8bb7-427f-9636-08ed5474f71b.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 164 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	a70ead03-6d2c-44c1-9ae5-f6c4094821ec	2024-05-14	Warnings	Exact identifier application number: M012
Day Time Cold and Flu Relief non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	cc450f89-a156-48e0-82ae-19782f13c2ca	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	a8df5c04-0f92-4013-b3e5-2b45009a7b8d	2024-05-13	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Safeway, Inc.	f762600a-f4b1-4869-a04b-8431c3d8a3e3	2024-05-13	Warnings	Exact identifier application number: M012
Cold and Flu DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Safeway, Inc.	ef0cd436-5e81-47a7-92d6-58495283ab28	2024-05-13	Warnings	Exact identifier application number: M012
Tussin Cough Sugar Free	DEXTROMETHORPHAN HBR GUAIFENESIN	P & L Development, LLC	7ed2fe86-3346-4308-a9b6-6a264f879b02	2024-05-09	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	10106c90-f2f0-508e-e063-6294a90a544b	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	1013ce02-7b12-335e-e063-6394a90af3e6	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	Kroger	10b08ea8-693e-eb18-e063-6394a90af548	2024-05-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b0bcff-d3bc-f70c-e063-6394a90a35ed	2024-05-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0e0a0-b878-0a9a-e063-6394a90a20e0	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime Honey	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0fa3d-d6b2-272a-e063-6394a90a1205	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	104
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	104
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	104
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	104
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	104
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	104
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	104
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	104
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	f9a0fb35-46d6-434f-8f9a-425a4bf50e84	104
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	104
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	e1d545dc-9222-4d61-964d-1c781215d7d2	102
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e1d545dc-9222-4d61-964d-1c781215d7d2	102
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e1d545dc-9222-4d61-964d-1c781215d7d2	102
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e1d545dc-9222-4d61-964d-1c781215d7d2	102
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e1d545dc-9222-4d61-964d-1c781215d7d2	102
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	5a60c923-8bb7-427f-9636-08ed5474f71b	6
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	5a60c923-8bb7-427f-9636-08ed5474f71b	6
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	5a60c923-8bb7-427f-9636-08ed5474f71b	6
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	5a60c923-8bb7-427f-9636-08ed5474f71b	6
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	5a60c923-8bb7-427f-9636-08ed5474f71b	6
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	42a0e577-a1b6-2c16-e063-6294a90af8e3	1
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	42a0e577-a1b6-2c16-e063-6294a90af8e3	1
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	42a0e577-a1b6-2c16-e063-6294a90af8e3	1
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	42a0e577-a1b6-2c16-e063-6294a90af8e3	1
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	42a0e577-a1b6-2c16-e063-6294a90af8e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58657-528-04	58657052804	120 mL in 1 BOTTLE (58657-528-04)	120 ml	2019-08-01	0000-00-00	No	No	Current
58657-528-16	58657052816	473 mL in 1 BOTTLE (58657-528-16)	473 ml	2019-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
M-Dryl	Bryant Ranch Prepack	2026-03-18	HUMAN OTC DRUG LABEL	104
M-Dryl	Bryant Ranch Prepack	2025-11-18	HUMAN OTC DRUG LABEL	102
M-Dryl	VERITYRX, LLC	2025-11-02	HUMAN OTC DRUG LABEL	1
M-Dryl	Method Pharmaceuticals, LLC	2025-10-21	HUMAN OTC DRUG LABEL	6
M-Dryl	Bryant Ranch Prepack	2024-11-27	HUMAN OTC DRUG LABEL	104