Childrens Allergy Relief

Product NDC: 49035-599
11-digit product format: 490350599
Labeler code: 49035
Product ID: 49035-599_26559824-1c95-404c-ba8a-c5db302aefc5
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-04-25
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/1
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	49035-599	49035-599-44	D	Discontinued by firm		2026-10-21

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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: Childrens Allergy Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/1

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
1049900	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
53a3e6a7-d625-4393-95eb-bb6f86e86cc1	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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	SPL version
49035-599-09	Childrens Allergy Relief	4 in 1 CARTON	TABLET, CHEWABLE	4	18
49035-599-09	Childrens Allergy Relief	5 in 1 BLISTER PACK	TABLET, CHEWABLE	5	18
49035-599-44	Childrens Allergy Relief	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6	18
49035-599-44	Childrens Allergy Relief	3 in 1 CARTON	TABLET, CHEWABLE	3	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-599-09	EA - Each	49035-599	8356e8c7-279e-4289-ae0d-7d22df552bcc	1	2025-07-08
49035-599-44	EA - Each	49035-599	2e1765a7-e105-4f70-bdf3-208b1438add3	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-599	CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WAL-MART STORES INC]	17	Current NDC, Legacy NDC, 4 package rows	20250110_53a3e6a7-d625-4393-95eb-bb6f86e86cc1.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 134 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	e07d880b-a12a-4e5e-94c0-bd36bcfe738c	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	bd0a3679-1f7c-4c41-e053-2995a90a8fcb	2024-12-03	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	bd09e4f3-3211-8c08-e053-2a95a90a73f9	2024-12-03	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b373a3a8-68c4-0187-e053-2995a90aad62	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All In One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCARE	a1b281ec-fd42-963c-e053-2a95a90a4b71	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	b3366ad4-5ef4-eb70-e053-2995a90acf33	2024-12-03	Warnings	Exact identifier application number: M012
Meijer Medicated Chest Rub, 3.53 oz. Lavender	MENTHOL, CAMPHOR, EUCALYPTUS OIL	Meijer Distribution	22516f25-b8aa-7511-e063-6394a90a6125	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd9513-1a42-e990-e063-6294a90a57df	2024-12-03	Warnings	Exact identifier application number: M012
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	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
1049900	diphenhydrAMINE HCl 12.5 MG Chewable Tablet	PSN	53a3e6a7-d625-4393-95eb-bb6f86e86cc1	18
1049900	diphenhydramine hydrochloride 12.5 MG Chewable Tablet	SCD	53a3e6a7-d625-4393-95eb-bb6f86e86cc1	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-599-09	49035059909	4 BLISTER PACK in 1 CARTON (49035-599-09) / 5 TABLET, CHEWABLE in 1 BLISTER PACK	4 blister pack	2011-04-25	0000-00-00	No	No	Current
49035-599-44	49035059944	6 in 1 BLISTER PACK						Historical