EZ Nite Sleep

Product NDC: 21130-014
11-digit product format: 211300014
Labeler code: 21130
Product ID: 21130-014_4d80361e-4854-47ec-b9bc-a09209e4f53d
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Safeway, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-06-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 50 mg/30mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: EZ Nite Sleep
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	50 mg/30mL

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
1248354	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
21a68c60-3005-43bb-8ec5-7982239c93f8	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
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
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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	SPL version
21130-014-06	EZ Nite Sleep	177 mL in 1 BOTTLE, PLASTIC	LIQUID	177	10
21130-014-12	EZ Nite Sleep	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	10
21130-014-24	EZ Nite Sleep	355 mL in 1 BOTTLE, PLASTIC	LIQUID	355	10
21130-014-24	EZ Nite Sleep	2 in 1 PACKAGE, COMBINATION	LIQUID	2	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-014	EZ NITE SLEEP (DIPHENHYDRAMINE HCL) LIQUID [SAFEWAY, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20240925_21a68c60-3005-43bb-8ec5-7982239c93f8.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 171 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banophen	DIPHENHYDRAMINE HCL	A-S Medication Solutions	e1b05e0c-3c61-4e2e-8e6c-ca1ed5bb93cd	2024-01-08	Warnings	Exact identifier application number: M012
AXIM DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	VIVUNT PHARMA LLC	0e7424ea-461f-5ead-e063-6294a90a41b6	2024-01-05	Warnings	Exact identifier application number: M012
AXIM Night Time - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	VIVUNT PHARMA LLC	0e740063-80d5-c48b-e063-6394a90a3b30	2024-01-05	Warnings	Exact identifier application number: M012
AXIM DayTime - Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	0e742e10-daea-6443-e063-6294a90ab5af	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	3c3e0dc8-cddd-4f46-9b68-19bac00c07cc	2024-01-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	A-S Medication Solutions	fa12a5a8-bf2d-4991-9d54-9c519e8e04cd	2024-01-04	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE 10mg	PHENYLPHRINE HCL	YYBA CORP	05824fc4-ef3f-4ebb-b601-252f76ad60ef	2024-01-03	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	5943d975-77e4-4cbd-b2d9-d699052fe82a	2024-01-01	Warnings	Exact identifier application number: M012
Coricidin HBP Cold and Flu	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	Proficient Rx LP	ac79a7dd-c26e-47d2-8fb9-768d2d09e507	2024-01-01	Warnings	Exact identifier application number: M012
Oxymethazoline HCL	OXYMETHAZOLINE HCL	Proficient Rx LP	96883e5f-18b5-4c1c-b984-756cb86be6ff	2024-01-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Proficient Rx LP	6e91b9c3-57e8-488b-ac70-d863cdf9d6e8	2024-01-01	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	9e067482-8735-4476-a82e-438dd24d4289	2024-01-01	Warnings	Exact identifier application number: M012
XL-3 Day Time	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	AptaPharma Inc.	94e02be4-b8a6-422a-8f66-e6a69e924b2c	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE	AptaPharma Inc.	8a4c55d0-c472-4e89-9fdb-17ecf0af4856	2023-12-30	Warnings	Exact identifier application number: M012
XL-3 Xtreme	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AptaPharma Inc.	dff79e0b-edf0-4dd3-a722-fd9beecd6293	2023-12-30	Warnings	Exact identifier application number: M012
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Salado Sales, Inc.	e25727d0-7dd7-4ef5-b064-7938679f075f	2023-12-29	Warnings	Exact identifier application number: M012
Maximum Strength DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	bb56d09d-ecb0-469e-a16f-f9f1a48942a8	2023-12-29	Warnings	Exact identifier application number: M012
Childrens Cough Mucus Relief	DEXTROMETHORPHANN HBR, GUAIFENESIN	Discount Drug Mart	2c27aca4-e1e2-419a-84c4-857718ca49da	2023-12-29	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	de2b2e34-62a5-451f-ab68-531d1c9d4d82	2023-12-29	Warnings	Exact identifier application number: M012
H E B MAX SEVERE CONGESTION and COUGH Maxium Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	d2b016ee-5329-45bf-9d71-d626204169cf	2023-12-29	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
1248354	diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution	PSN	21a68c60-3005-43bb-8ec5-7982239c93f8	10
1248354	diphenhydramine hydrochloride 1.67 MG/ML Oral Solution	SCD	21a68c60-3005-43bb-8ec5-7982239c93f8	10
1248354	diphenhydramine HCl 1.667 MG/ML Oral Solution	SY	21a68c60-3005-43bb-8ec5-7982239c93f8	10
1248354	diphenhydramine HCl 50 MG per 30 ML Oral Solution	SY	21a68c60-3005-43bb-8ec5-7982239c93f8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-014-06	21130001406	177 mL in 1 BOTTLE, PLASTIC (21130-014-06)	177 ml	2015-06-30	0000-00-00	No	No	Current
21130-014-12	21130001412	355 mL in 1 BOTTLE, PLASTIC (21130-014-12)	355 ml	2015-06-30	0000-00-00	No	No	Current
21130-014-24	21130001424	2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (21130-014-24) / 355 mL in 1 BOTTLE, PLASTIC		2015-06-30	0000-00-00	No	No	Current