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 4 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	WAL-MART STORES INC	888bd90a-a059-4814-bd65-6b735ecfaf3a	2026-08-31	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime and Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	49a98411-aa5a-6de3-e063-6294a90a148f	2026-08-31	Warnings	Exact identifier application number: M012
equate daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE	Sixarp, LLC	5a5a6917-9fb5-e6ca-e063-6394a90af9dc	2026-08-31	Warnings	Exact identifier application number: M012
Zicam Intense Sinus Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	d916f7ff-84b7-57ef-e053-2995a90a3efa	2026-08-31	Warnings	Exact identifier application number: M012
Afrin Original Nasal	OXYMETAZOLINE HYDROCHLORIDE	JC World Bell Wholesale Co., Inc.	ecfa14b8-a3f3-4569-b489-c9e1a51cf09e	2026-08-31	Warnings	Exact identifier application number: M012
Dextromethorphan HBr	DEXTROMETHORPHAN HBR	BIONPHARMA INC.	5a5dde85-8785-8149-e063-6294a90a4d57	2026-08-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Sixarp, LLC	5a5e2458-bab0-4931-e063-6394a90ad606	2026-08-31	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF	DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL	Reckitt Benckiser LLC	8d670d91-9e22-45b9-b568-5b62c2133d32	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21	2026-08-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	67849e09-2056-4013-98b1-d003ed3250a2	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion Sugar Free	GUAIFENESIN	Akron Pharma Inc.	3b023b91-e703-4599-9864-96d8c328b45c	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Mucus and Chest Congestion	GUAIFENESIN	Akron Pharma Inc.	ac874a31-5556-4669-937f-dcb52aaecd8a	2026-08-31	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	e0ce4287-bfa1-4413-97c8-4fe2e39bda36	2026-08-31	Warnings	Exact identifier application number: M012
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	24173e77-92ec-4a87-a471-d6867837c180	2026-08-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	69af44c2-390c-4223-889a-d5555aef5778	2026-08-28	Warnings	Exact identifier application number: M012
Tussin DM Daytime	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	432d4833-2eaf-4f7c-b6b4-41043a6b7e2a	2026-08-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Your Military Exchanges	13fcc43c-bdda-4b65-b6d7-23b39e683651	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M012
Multi-Symptom Allergy	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreen Company	5170c450-989d-44fa-ab38-86c78feae3b6	2026-08-28	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	54cbbc5f-908b-47b2-b37f-3646354d3568	2026-08-27	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Hyvee Inc	4e578c7a-88d4-e4cd-e063-6394a90aac44	2026-08-27	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