Childrens Allergy

Product NDC: 69676-0074
11-digit product format: 696760074
Labeler code: 69676
Product ID: 69676-0074_2ea022ca-e2ee-3856-e063-6294a90a484f
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Genexa Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-26
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

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 · 6 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
2025-02-02 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	69676-0074-9	`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	69676-0074-9	`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	69676-0074-9	`0efc9e666f02…`	`f202fb6c5f17…`

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: Childrens Allergy
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
e880b8d7-61c3-41cc-e053-2995a90aaaeb	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69676-0074-9	2025-02-26	C162847	48780-1	2cef2736-a29d-d83d-e063-dadaa90ab31f	Children's Allergy
69676-0074-9	2025-01-30	C162847	48780-1	2cef2736-a29d-d83d-e063-dadaa90ab31f	Children's Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69676-0074-9	Childrens Allergy	1 in 1 CARTON	SOLUTION	1		2
69676-0074-9	Childrens Allergy	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69676-0074	CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [GENEXA INC.]	2	Current NDC, 2 package rows	20250228_e880b8d7-61c3-41cc-e053-2995a90aaaeb.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 2 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vicks childrens Cough Congestion	PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN	The Procter & Gamble Manufacturing Company	e2356457-9791-3710-e053-2995a90ad140	2026-09-08	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	077fac1a-0ec5-40d9-8861-a281b48f650a	2026-09-08	Warnings	Exact identifier application number: M012
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	RARITAN PHARMACEUTICALS	eef00453-9f4f-4a05-bb4e-49b94705b52c	2026-09-08	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	RARITAN PHARMACEUTICALS INC	9819155b-2713-42be-867e-16605e7643d0	2026-09-08	Warnings	Exact identifier application number: M012
Cold and Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE	WALMART INC.	f9d1dfd1-527f-491d-9188-14886ac70ced	2026-09-08	Warnings	Exact identifier application number: M012
severe cold and cough daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	3ce8508e-7d9d-4413-858a-8f952e760c01	2026-09-08	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	RARITAN PHARMACEUTICALS INC	d9606c9a-31b1-4121-9870-809a05f5b68a	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief DM Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	RARITAN PHARMACEUTICALS INC	4898b1c2-55ef-4589-982b-2279c01707e5	2026-09-08	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association, Inc.	2a7afe03-3c34-4e30-827e-b3bb2568cb97	2026-09-08	Warnings	Exact identifier application number: M012
Drx Choice childrens allergy chews	DIPHENHYDRAMINE HCL	RARITAN PHARMACEUTICALS INC	dd2be906-bd0a-437c-9693-54b9391a5da3	2026-09-05	Warnings	Exact identifier application number: M012
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	49235f4f-e661-4a83-88ef-b9a956848777	2026-09-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	71845bf9-8981-4ca0-a62c-dbef102b1b02	2026-09-04	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	774d2bde-9f57-4ced-800a-cada39c685ed	2026-09-04	Warnings	Exact identifier application number: M012
Nostrilla	OXYMETAZOLINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	86217847-8e2b-48cc-b289-4987fd3aa7c3	2026-09-04	Warnings	Exact identifier application number: M012
tussin cough chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Rite Aid Corporation	86fc3723-5fc5-4de5-bd04-7774c2abe539	2026-09-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Topco Associates, LLC	ed576bf1-3949-423e-af2e-e4b1a3839b21	2026-09-04	Warnings	Exact identifier application number: M012
tussin nighttime cough	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	80d51af8-3a7b-4d22-8d4f-df5f91913047	2026-09-04	Warnings	Exact identifier application number: M012
NO MORE NOSEBLEED	OXYMETAZOLINE HYDROCHLORIDE	DR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.	69d3f1fe-b476-4f84-8c5e-94957b74b46c	2026-09-04	Warnings	Exact identifier application number: M012
Ultra Fine Mist Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	DOLGENCORP, INC.	5f134840-2465-4585-a85d-08d746f76f7a	2026-09-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE	Family Dollar (FAMILY WELLNESS)	22918db6-9096-4eb8-a742-aaa2dd5c31da	2026-09-03	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	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69676-0074-9	69676007409	1 BOTTLE, PLASTIC in 1 CARTON (69676-0074-9) / 118 mL in 1 BOTTLE, PLASTIC	2022-04-26	No	No	Current