allergy relief

Product NDC: 59779-874
11-digit product format: 597790874
Labeler code: 59779
Product ID: 59779-874_5cad0028-2e5f-4960-98fc-9e94b08be368
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-09-03
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59779-874	59779-874-34	D	Discontinued by firm		2026-10-27

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59779-874	59779-874-34	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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 relief
Brand name suffix: childrens
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

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, Related label table
NDC	Related label
59779-874-26	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-26	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-26	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts
59779-874-34	CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59779-874-26	allergy reliefchildrens	1 in 1 CARTON	SOLUTION	1	6
59779-874-26	allergy reliefchildrens	118 mL in 1 BOTTLE	SOLUTION	118	6
59779-874-34	allergy reliefchildrens	1 in 1 CARTON	SOLUTION	1	6
59779-874-34	allergy reliefchildrens	236 mL in 1 BOTTLE	SOLUTION	236	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-874-26	ML - Milliliter	59779-874	4cb4a87c-bcfb-4160-b09a-2fd30df77cc3	1	2018-02-20
59779-874-34	ML - Milliliter	59779-874	18e840bb-3189-47a4-b0dc-65becdfa0083	1	2018-02-20

DailyMed Socrata Ingredients#

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

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 168 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	3dc293c9-736b-4bd8-b993-ff83b9909bcd	2024-02-23	Warnings	Exact identifier application number: M012
Childrens Dibromm Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Cardinal Health (Leader) 70000	10cc7d67-30c4-4451-bf74-78abae3c8e25	2024-02-23	Warnings	Exact identifier application number: M012
Nasal Spray, 24-7 for Life	OXYMETAZOLINE HYDROCHLORIDE 0.05%	Lil' Drug Store Products, Inc.	11d27c75-fd95-f9da-e063-6394a90ac6b0	2024-02-20	Warnings	Exact identifier application number: M012
Nighttime Cold and Cough childrens	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	11652e8a-2242-4449-8a41-a8e75509025e	2024-02-20	Warnings	Exact identifier application number: M012
Severe Sinus Relief Mist	OXYMETAZOLINE SPRAY	Walgreens Company	847f47d9-62b1-49a3-8bb3-9bf275685bd2	2024-02-14	Warnings	Exact identifier application number: M012
Allergy Sinus, Lil Drug Store	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE	Lil' Drug Store Products, Inc.	1145440e-b37a-6e5e-e063-6294a90ab4a0	2024-02-13	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	A-S Medication Solutions	36140639-e7a8-43bc-83e2-469430af9d1a	2024-02-13	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	ff48b55a-0d32-47d6-941d-d99c7cf52f94	2024-02-12	Warnings	Exact identifier application number: M012
Childrens Robitussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	15950273-14c9-4a0b-bbb4-683048add722	2024-02-08	Warnings	Exact identifier application number: M012
THERAFLU Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Haleon US Holdings LLC	7d902237-a990-4c5e-875b-291e124e143b	2024-02-03	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	0f2d371d-f890-41e5-ac11-db5559d32466	2024-02-02	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	4daca846-8511-4303-9e6c-9469f7f260ba	2024-02-02	Warnings	Exact identifier application number: M012
CVS Health COUGH SUPPRESSANT SOFTGEL	DEXTROMETHORPHAN HYDROBROMIDE	CVS Pharmacy, Inc.	f676dfeb-fba8-419d-8a47-c3880e4100cc	2024-02-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu ReadyInCase	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	P & L Development, LLC	155a7168-b568-41f4-b8a2-214889b4eccf	2024-02-02	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	Rejoice International Corp.	104e1a38-3472-b9e2-e063-6294a90a38cf	2024-02-01	Warnings	Exact identifier application number: M012
Vaporizing Chest Rub Lavender 4oz	CAMPHOR/MENTHOL	China Ningbo Shangge Cosmetics Technology Corp.	104f5b07-eed2-566c-e063-6294a90a6505	2024-02-01	Warnings	Exact identifier application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	5962a73e-72e4-493b-94a7-43bc6cf9c82f	2024-02-01	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	e5ef7b85-feee-44a7-bd0e-ed91352c7434	2024-01-31	Warnings	Exact identifier application number: M012
SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	17a07d2d-f2da-4e51-9a77-6f0c174987bb	2024-01-31	Warnings	Exact identifier application number: M012
Maximum strength Max Cold and Sinus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	AptaPharma Inc.	263dae13-5f92-4505-8bcc-e903d05b9a0c	2024-01-31	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	8b539dc0-5487-4b11-babd-52bf341a8947	6
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	8b539dc0-5487-4b11-babd-52bf341a8947	6
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	8b539dc0-5487-4b11-babd-52bf341a8947	6
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	8b539dc0-5487-4b11-babd-52bf341a8947	6
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	8b539dc0-5487-4b11-babd-52bf341a8947	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-874-26	59779087426	1 BOTTLE in 1 CARTON (59779-874-26) / 118 mL in 1 BOTTLE	1 bottle	2015-09-03	0000-00-00	No	No	Current
59779-874-34	59779087434	1 BOTTLE in 1 CARTON (59779-874-34) > 236 mL in 1 BOTTLE	1 bottle	2015-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Children’s Allergy Relief Drug Facts	CVS Pharmacy	2026-09-23	HUMAN OTC DRUG LABEL	7