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 167 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Medi-Soothers	DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL	Haleon US Holdings LLC	4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5	2024-04-06	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HBR, GUAIFENESIN	DEXTROMETHORPHAN HBR, GUAIFENESIN	OPMX LLC	9a16e7f3-78aa-0b01-e053-2a95a90ab19c	2024-04-05	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime Honey Ginger	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	44404c6a-8031-4f4b-a48e-3739a11a0d2c	2024-04-05	Warnings	Exact identifier application number: M012
Activcin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	e06a4d72-cc8d-fd9d-e053-2995a90a7a76	2024-04-05	Warnings	Exact identifier application number: M012
Coldtac Plus Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	ff5ce5c6-a03f-2ad3-e053-6394a90a99f6	2024-04-05	Warnings	Exact identifier application number: M012
Desresfriol-DX Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	OPMX LLC.	ff5e0e0f-bfd2-b02b-e053-6394a90afe8a	2024-04-05	Warnings	Exact identifier application number: M012
Leader Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Cardinal Health 110,Inc	98bf8e84-b555-4b5a-90a0-7837a5560289	2024-04-03	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Advanced Rx LLC	38299cf3-e884-4676-8cc4-6dd64e7d023c	2024-03-30	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Advanced Rx LLC	d1542362-19c5-4470-89e8-87d26e2ca8ed	2024-03-30	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