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 28 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Mucus Cough and Congestion Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	8b5d391b-6c23-44c3-81d0-c08822bf6d01	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Night Time Multi-Symptom Cold	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	e048cd53-a3cd-484f-a972-4cb49791dba3	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	b8132c81-5291-431a-ad3a-ec8a3eb21c19	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Stuffy Nose and Chest Congestion	GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	7354f57c-0ecf-481f-9482-0040c90c4350	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	5bda415d-739f-4ca5-b5b2-07c14a81863b	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8f3eb5c5-832e-4806-b3da-ef112cf55dcf	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDE	Reckitt Benckiser LLC	e3aea6df-37a4-43c5-a192-a902cbff3f92	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9e5a8d7-814c-4ab1-bb05-e4cb9155978e	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple Pack	ACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	Reckitt Benckiser LLC	c7ab5201-8550-4bf4-957c-c8f049aeaa4a	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	84e7be8f-2785-45ef-9c44-de05394fcd99	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	771d7fd8-184f-48a3-90ed-e8f00159d97e	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX Childrens Stuffy Nose	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	de1c0abd-1644-4351-8106-e9df6ca5c142	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Childrens Fever Sore Throat and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1538a75d-582a-9501-e063-6394a90a6c55	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	19105007-0193-0764-e063-6294a90a01a4	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	34fd2458-9acd-cdf7-e063-6394a90a3d0a	2026-05-18	Warnings	Exact identifier application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3a24b06c-00a6-c2ef-e063-6294a90a4d72	2026-05-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Reckitt Benckiser LLC	14be3ab0-d6ae-e342-e063-6294a90ab851	2026-05-18	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Bryant Ranch Prepack	20f00537-2c8a-45d1-8e5f-ec276d0a47b6	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	38df2308-f6f9-4476-ad34-4b5bc5f9fdf2	2026-05-18	Warnings	Exact identifier application number: M012
Allergy Plus Headache Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	88e3b969-79d0-4e64-95c0-c5cfd41e365f	2026-05-18	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