allergy

Product NDC: 42507-379
11-digit product format: 425070379
Labeler code: 42507
Product ID: 42507-379_fb9454f6-8b77-4736-86d6-ab0e423b0077
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: HyVee Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1992-11-11
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: 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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-379-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-379-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-379-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-379-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-379-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-379-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-379-26	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-379-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-379-26	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-379-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-379-26	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-379-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: allergy
Listing expiration: 2027-12-31

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
75b19163-db1c-42fc-8bbb-364be16b9b2f	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
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
42507-379-00	allergy	118 mL in 1 BOTTLE	SOLUTION	118		5
42507-379-26	allergy	1 in 1 CARTON	SOLUTION	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [HYVEE INC]	2

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 1 of 196 · 3,909 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Vicks Sinex SEVERE CONGESTION MOISTURIZING ULTRA FINE MIST	OXYMETAZOLINE HYDROCHLORIDE	Procter & Gamble Manufacturing GmbH	464534ee-15f8-3af8-e063-6394a90a3f18	2026-08-24	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-20	Warnings	Exact identifier application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	4d94968b-ada3-4344-8563-cba7fc491d74	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus chest congestion	GUAIFENESIN	CVS PHARMACY	bec04049-03b2-4465-9cf5-0ad2ef8014ef	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY, INC	fe12f3bd-3237-42d1-aec5-c831b9637175	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9	2026-08-19	Warnings	Exact identifier application number: M012
CVS Long Acting Cough	DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	31a7c0e2-af1c-45dd-8a93-e0879cae6005	2026-08-19	Warnings	Exact identifier application number: M012
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	b3baf939-a9fd-47ac-9bc7-68435e32ea1e	2026-08-19	Warnings	Exact identifier application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	5151127a-4d09-413a-a08b-f76fb77e1188	2026-08-19	Warnings	Exact identifier application number: M012
CVS DT and NT Combo Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	360c8c62-0945-4031-b291-d40c4270b940	2026-08-19	Warnings	Exact identifier application number: M012
equate childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	24758ab0-ba08-4b4a-9861-449612bdb89c	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus plus Chest Congestion	GUAIFENESIN	CVS PHARMACY	3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	CVS	7dc30e46-e289-40fc-b217-b123fee5daee	2026-08-19	Warnings	Exact identifier application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY	4490a7e1-d5b9-459c-8751-c24486807981	2026-08-19	Warnings	Exact identifier application number: M012
CVS DayTime and NightTime Value Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	4c813cd5-2c97-4fc3-926c-1a0396551a31	2026-08-19	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	75b19163-db1c-42fc-8bbb-364be16b9b2f	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	75b19163-db1c-42fc-8bbb-364be16b9b2f	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	75b19163-db1c-42fc-8bbb-364be16b9b2f	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	75b19163-db1c-42fc-8bbb-364be16b9b2f	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	75b19163-db1c-42fc-8bbb-364be16b9b2f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-379-00	42507037900	118 mL in 1 BOTTLE	118 ml				Historical
42507-379-26	42507037926	1 BOTTLE in 1 CARTON (42507-379-26) / 118 mL in 1 BOTTLE (42507-379-00)	1 bottle	1992-11-11	No	No	Current