Childrens Allergy Relief

Product NDC: 68998-505
11-digit product format: 689980505
Labeler code: 68998
Product ID: 68998-505_4653161c-6665-afeb-e063-6294a90af6bb
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Marc Glassman, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-02
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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68998-505-24	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68998-505-24	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68998-505-24	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68998-505-24	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68998-505-24	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68998-505-24	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68998-505-24	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68998-505-24	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68998-505-24	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68998-505-24	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68998-505-24	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68998-505-24	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68998-505-24	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68998-505-24	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68998-505-24	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68998-505-24	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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 Relief
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
e916ef86-ca73-42dd-83dc-6033f56d96f2	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
68998-505-24	2025-12-19	C162847	48780-1	f386c649-f66f-0266-e053-dadaa90a7c1a	e916ef86-ca73-42dd-83dc-6033f56d96f2
68998-505-24	2023-01-30	C162847	48780-1	f386c649-f66f-0266-e053-dadaa90a7c1a	e916ef86-ca73-42dd-83dc-6033f56d96f2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68998-505-24	Childrens Allergy Relief	118 mL in 1 BOTTLE	LIQUID	118		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68998-505	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [MARC GLASSMAN, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20200118_e916ef86-ca73-42dd-83dc-6033f56d96f2.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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	3148f80f-8a0d-4b6c-85be-79085fc04444	2026-08-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	aa7164a7-f842-457d-abee-0740bb8c1c90	2026-08-19	Warnings	Exact identifier application number: M012
CVS	CHILDRENS STUFFY NOSE AND COLD	CVS PHARMACY, INC	6cff265d-94a3-4617-a366-fe970d97f05a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Congestion and Pain Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS	5a8e4320-bae1-4831-b66b-9babfe8888d6	2026-08-19	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	CVS PHARMACY	0ae0c244-e019-4b35-890c-8e15e3d3f7ce	2026-08-19	Warnings	Exact identifier application number: M012
CVS Severe Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	e32881f5-2bb5-4756-aa86-a09473ab590b	2026-08-19	Warnings	Exact identifier application number: M012
Good Sense Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	L. Perrigo Company	d2541ef0-a73c-43aa-91ff-fdbce2748c4f	2026-08-18	Warnings	Exact identifier application number: M012
CVS Severe Nasal Congestion Relief Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	5a7e42ee-810c-4bc1-9d8d-fac8e849e126	2026-08-18	Warnings	Exact identifier application number: M012
DAYTIME NIGHTTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	8dd039b4-209a-484a-b15e-741d55087a93	2026-08-18	Warnings	Exact identifier application number: M012
CVS Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	CVS PHARMACY	558b7ed6-a9f6-452c-90cd-df8258663bf1	2026-08-18	Warnings	Exact identifier application number: M012
Extra Strength Nasal	PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	7acf1a9a-bd97-48bb-8025-ac26070378a2	2026-08-18	Warnings	Exact identifier application number: M012
Polytussin DM	DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE	Poly Pharmaceuticals, Inc.	fda8f594-82bf-1781-e053-6294a90ad344	2026-08-18	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max Honey and Berry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	da1f1ef9-a974-4998-8e1d-c1d999596943	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	89168715-71b1-424e-8dae-fcfa90bc85bf	2026-08-18	Warnings	Exact identifier application number: M012
CVS Health Sinus	OXYMETAZOLINE HYDROCHLORIDE	CVS PHARMACY, INC.	c7840511-3a4f-4547-ae90-19b085a5874e	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health	NASAL OXYMETAZOLINE HCL	CVS Pharmacy,Inc.	56f08e70-bf16-4933-97bc-177bc190d12a	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	ALLERGY NASAL	CVS PHARMACY,INC.	3e76ffac-07a7-4b6a-bc4c-9cabb653e064	2026-08-17	Warnings	Exact identifier application number: M012
CVS dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	2026-08-17	Warnings	Exact identifier application number: M012
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	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	e916ef86-ca73-42dd-83dc-6033f56d96f2	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	e916ef86-ca73-42dd-83dc-6033f56d96f2	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	e916ef86-ca73-42dd-83dc-6033f56d96f2	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	e916ef86-ca73-42dd-83dc-6033f56d96f2	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	e916ef86-ca73-42dd-83dc-6033f56d96f2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68998-505-24	68998050524	118 mL in 1 BOTTLE (68998-505-24)	118 ml	2014-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Allergy Relief - Marc Glassman, Inc.	Marc Glassman, Inc.	2025-12-19	HUMAN OTC DRUG LABEL	3