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		2026-10-16

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 97 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rompe Pecho DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	d108c712-bc36-41d7-9ccd-720496b5599e	2025-10-14	Warnings	Exact identifier application number: M012
Rompe Pechito DM for Kids	DEXTROMETHORPHAN HBR, GUAIFENESIN	Efficient Laboratories Inc	004d12e1-6e3d-84c8-e063-6394a90aa653	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF CP Allergy / Cough	CHLOPHEDIANOL HCL, PYRILAMINE MALEATE	GM Pharmaceuticals, INC	0bdea30a-39da-6611-e063-6394a90aa4cf	2025-10-14	Warnings	Exact identifier application number: M012
VANACOF	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	cf3886ab-62b3-497a-a587-18cbfbaf3634	2025-10-14	Warnings	Exact identifier application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	42d4bafb-b630-487e-b63d-13ad37a59454	2025-10-14	Warnings	Exact identifier application number: M012
SUPRESS A	DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	410c19f7-213d-cd99-e063-6294a90af5a3	2025-10-13	Warnings	Exact identifier application number: M012
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	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