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…`

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: 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 139 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUDAFED PE Head Congestion Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	1e528f78-0ced-4a06-935a-84056c921727	2024-11-08	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	657a1e59-104c-4152-b2c9-00a8b82dc78e	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	47c61858-72ce-409b-a3af-a63620cf7d13	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	b8b75904-3806-4258-89c1-d6ff486ed41c	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	464de5de-0e7a-41d6-875f-dd0e5fe7893c	2024-11-08	Warnings	Exact identifier application number: M012
McKesson Phenylephrine HCl	PHENYLEPHRINE HCL	McKesson Medical-Surgical	e09060f7-ca0b-5f7c-e053-2995a90ab344	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e0e216ef-300c-4f57-87e6-62a5327e09b4	2024-11-08	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	969c0718-ba6e-4edb-9f55-43bc9500450f	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	62a70d9a-4e78-497c-8f75-012ab94e92f6	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Publix Super Markets Inc	25b2ad8a-5835-4496-815f-73a7fb40dcfd	2024-11-08	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	296f20c0-8b5f-4a08-9329-f93c92e63867	2024-11-08	Warnings	Exact identifier application number: M012
topcare tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Topco Associates LLC	d3cae69e-41a5-4099-a3f4-ce25fd94df73	2024-11-08	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	9d147d1e-8ea5-4e0f-8ae8-1da16f119496	2024-11-08	Warnings	Exact identifier application number: M012
equate adult cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	WALMART INC.	e770bdb2-3662-4538-8199-fe4a4059c720	2024-11-08	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	23dcb627-c867-435f-9d1a-a9f49e58b58f	2024-11-08	Warnings	Exact identifier application number: M012
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	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