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Childrens Allergy Relief Dye Free Bubble Gum Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid — NDC 81522-0293-04 package photo

Childrens Allergy Relief Dye Free Bubble Gum Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid

by FSA Store Inc. (Caring Mills) · 1 BOTTLE, PLASTIC in 1 CARTON (81522-293-04) / 118 mL in 1 BOTTLE, PLASTIC
NDC 81522-0293-04
🏷️ FDA NDC (as labeled) 81522-293-04 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 81522-293-04
Product NDC 81522-293
11-digit billing NDC 81522029304
RxCUI 1049906
UNII TC2D6JAD40
Application # M012
SPL Set ID 9a384e6f-f5b4-4daf-b268-d2d853eca002
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2022-04-18
Route ORAL
Dosage form LIQUID
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 81522-293-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81522-0293-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerFSA Store Inc. (Caring Mills)
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code81522
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 Read our full Diphenhydramine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 12.5 mg/5mL 63868-0370-04 QUALITY 1 bottle $0.016 — FDA listed —
Childrens Allergy 12.5 mg/5mL 63868-0823-54 QUALITY 1 bottle $0.016 — FDA listed —
Childrens Allergy Relief Dye Free 12.5 mg/5mL 70000-0693-01 CARDINAL 1 bottle $0.016 — Availability likely —
Diphenhydramine HCl 12.5 mg/5mL 00904-6985-16 Major 473 ml $0.018 — Availability likely —
Allergy Relief Childrens 12.5 mg/5mL 00904-7533-15 Major 473 ml $0.018 — Availability likely —
Allergy Relief 12.5 mg/5mL 54859-0811-16 LLORENS 473 ml $0.018 — Availability likely —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 81033-0029-16 Kesin 473 ml $0.018 — Availability likely —
good sense allergy 12.5 mg/5mL 00113-0379-26 L. 1 bottle $0.020 — Availability likely —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 24385-0379-26 Amerisource 1 bottle $0.020 — Availability likely —
Allergy Relief 50 mg/20mL 46122-0685-26 Amerisource 1 bottle $0.020 — Availability likely —
Good NeighborChildrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 46122-0793-29 AMERISOURCE 1 bottle $0.020 — Availability likely —
Diphenhydramine Oral Liquid 12.5 mg/5mL 57237-0305-12 Rising 118 ml $0.020 — Availability likely —
M-Dryl 12.5 mg/5mL 58657-0528-04 Method 120 ml $0.020 — Availability likely —
leader childrens allergy relief 12.5 mg/5mL 70000-0474-01 Cardinal 1 bottle $0.020 — Availability likely —
Childrens Allergy Relief 12.5 mg/5mL 70000-0701-01 Cardinal 1 bottle $0.020 — Availability likely —
foster and thrive childrens allergy relief 12.5 mg/5mL 70677-1268-01 Strategic 1 bottle $0.020 — Availability likely —
Diphenhydramine Hcl 12.5 Mg Per 5 Ml 12.5 mg/5mL 82568-0016-04 AARNA 118 ml $0.020 — Availability likely —
Foster and Thrive Childrens Allergy Relief 12.5 mg/5mL 70677-1012-01 Strategic 1 bottle $0.020 — Availability likely —
Quality Choice Dye Free Cherry Childrens Allergy Relief 12.5 mg/5mL 83324-0016-04 Chain 1 bottle $0.027 — FDA listed —
Diphenhydramine Hydrochloride 12.5 mg/5mL 00121-0489-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00121-0865-00 PAI 10 cups — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 00121-0978-00 PAI 10 cups — AA FDA listed —
Diphenhydramine HCl 25 mg/10mL 00121-1730-00 PAI 10 cups — — FDA listed —
Wal Dryl Childrens Allergy 12.5 mg/5mL 00363-0092-08 Walgreens 1 bottle — — FDA listed —
Dye Free Wal Dryl Allergy childrens 12.5 mg/5mL 00363-0293-04 Walgreens 1 bottle — — FDA listed —
childrens Allergy Dye Free Wal Dryl 12.5 mg/5mL 00363-0710-08 WALGREEN 1 bottle — — FDA listed —
childrens allergy relief 12.5 mg/5mL 00363-1236-26 Walgreen 1 bottle — — FDA listed —
Adult Allergy Relief Dye Free 25 mg/10mL 00363-7100-04 WALGREEN 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 00363-8018-36 Walgreen 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 00904-7323-70 Major 100 cups — — Discontinued —
Diphenhydramine HCl Oral Solution 25 mg/10mL 00904-7324-72 Major 100 cups — — Discontinued —
Diphenhydramine HCl 25 mg/10mL 00904-7559-72 Major 10 cups — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 00904-7560-70 Major 10 cups — — FDA listed —
Children Allergy Relief Bubblegum flavor 12.5 mg/5mL 11673-0832-04 TARGET 1 bottle — — FDA listed —
childrens allergy relief dye-free 12.5 mg/5mL 11673-0918-36 Target 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 11822-0379-00 Rite 1 bottle — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 11822-0918-01 Rite 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 21130-0025-04 Safeway, 118 ml — — FDA listed —
Childrens Dye Free Allergy Relief 12.5 mg/5mL 21130-0563-05 BETTER 1 bottle — — Discontinued —
Bactimicina Childrens Allergy 12.5 mg/5mL 24286-1565-04 DLC 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 30142-0404-26 Kroger 1 bottle — — FDA listed —
childrens allergy 12.5 mg/5mL 30142-0651-26 Kroger 1 bottle — — FDA listed —
Topcare childrens allergy 12.5 mg/5mL 36800-0379-26 Topco 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 37808-0012-08 H 1 bottle — — FDA listed —
Allergy 12.5 mg/5mL 37808-0379-26 H 1 bottle — — FDA listed —
equaline allergy 12.5 mg/5mL 41163-0379-26 United 1 bottle — — FDA listed —
KROGER Dye Free Childrens Allergy Relief 12.5 mg/5mL 41226-0710-08 KROGER 1 bottle — — FDA listed —
allergy childrens 12.5 mg/5mL 41250-0379-26 Meijer 1 bottle — — FDA listed —
Meijer Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 41250-0710-08 MEIJER 1 bottle — — FDA listed —
CareOne Childrens Allergy Relief 12.5 mg/5mL 41520-0632-26 American 1 bottle — — FDA listed —
allergy 12.5 mg/5mL 42507-0379-26 HyVee 1 bottle — — FDA listed —
equate allergy relief 12.5 mg/5mL 49035-0379-26 Wal-Mart 1 bottle — — FDA listed —
Dye Free Childrens Allergy Relief 12.5 mg/5mL 49035-0600-04 WAL-MART 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 49580-0292-02 P 118 ml — — FDA listed —
Childrens Dye Free Allergy 12.5 mg/5mL 49580-0293-04 P 1 bottle — — FDA listed —
children allergy relief dye free cherry 12.5 mg/5mL 50090-6163-00 A-S 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 50090-6541-00 A-S 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50090-7824-00 A-S 1 bottle — — FDA listed —
Childrens Benadryl ALLERGY 12.5 mg/5mL 50580-0534-04 Kenvue 1 bottle — — FDA listed —
Childrens Benadryl DYE-FREE ALLERGY 12.5 mg/5mL 50580-0535-01 Kenvue 1 bottle — — FDA listed —
BENADRYL Allergy 12.5 mg/5mL 50580-0573-04 Kenvue 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 50844-0015-19 L.N.K. 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0150-19 CVS 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 51316-0180-19 CVS 1 bottle — — FDA listed —
CVS dye-free childrens allergy 12.5 mg/5mL 51316-0710-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53942-0505-24 DeMoulas 118 ml — — FDA listed —
Childrens Allergy 12.5 mg/5mL 53943-0505-26 Discount 237 ml — — FDA listed —
Allergy Relief 12.5 mg/5mL 54859-0837-04 LLORENS 118 ml — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 55319-0315-36 Family 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 55319-0918-36 Family 1 bottle — — FDA listed —
Allergy Childrens 12.5 mg/5mL 55910-0124-36 DOLGENCORP, 1 bottle — — FDA listed —
dg health allergy childrens 12.5 mg/5mL 55910-0379-26 Dolgencorp, 1 bottle — — FDA listed —
Allergy Childrens Allergy 12.5 mg/5mL 55910-0891-04 Dolgencorp, 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 56062-0379-26 Publix 1 bottle — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 57237-0317-51 Rising 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 57237-0318-11 Rising 100 cups — — FDA listed —
Geri Dryl 12.5 mg/5mL 57896-0980-16 GERI-CARE 473 ml — — FDA listed —
CVS Health Childrens Allergy Relief 12.5 mg/5mL 59779-0793-10 CVS 10 vials — — FDA listed —
allergy relief childrens 12.5 mg/5mL 59779-0874-26 CVS 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 60687-0829-86 American 10 cups — — FDA listed —
Diphenhydramine HCl 25 mg/10mL 60687-0830-08 American 10 cups — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1159-01 Bryant 120 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 63629-1160-01 Bryant 473 ml — — FDA listed —
Dye Free Allergy childrens 12.5 mg/5mL 63868-0128-04 QUALITY 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 63941-0292-04 Best 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 63941-0505-26 Best 1 bottle — — FDA listed —
Best Choice Childrens Allergy Relief Bubblegum flavor 12.5 mg/5mL 63941-0710-04 BEST 1 bottle — — FDA listed —
Winco Foods Childrens Allergy Relief Dye Free 12.5 mg/5mL 67091-0354-18 WINCO 1 bottle — — FDA listed —
good sense allergy 12.5 mg/5mL 68071-3734-04 NuCare 1 bottle — — FDA listed —
ADWE dye-free childrens allergy 12.5 mg/5mL 68163-0710-08 RARITAN 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 68788-7994-01 Preferred 1 bottle — — FDA listed —
Diphenhydramine HCl 12.5 mg/5mL 68788-8274-01 Preferred 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 68998-0505-24 Marc 118 ml — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 69168-0471-59 Allegiant 1 bottle — — FDA listed —
Allergy Relief 12.5 mg/5mL 69256-0292-08 Harris 1 bottle — — Discontinued —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 69339-0151-17 Natco 10 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 69339-0152-17 Natco 10 cups — — FDA listed —
Kids Allergy 12.5 mg/5mL 69676-0039-09 Genexa 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 69676-0074-09 Genexa 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0174-36 CVS 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 69842-0719-19 CVS 1 bottle — — FDA listed —
Allergy Relief 50 mg/20mL 69842-0798-36 CVS 1 bottle — — FDA listed —
Good Neighbor Pharmacy Childrens Allergy 12.5 mg/5mL 71205-0259-04 Proficient 1 bottle — — FDA listed —
Max Allergy Kids 12.5 mg/5mL 71399-0023-04 Akron 118 ml — — FDA listed —
Diphenhydramine HCL STRAWBERRY FLAVOR 12.5 mg/5mL 71800-0058-19 Innovida 119 ml — — FDA listed —
Diphenhydramine Hydrochloride 25 mg/10mL 71872-7242-01 Medical 1 cup — AA FDA listed —
M-Dryl 12.5 mg/5mL 72162-1674-02 Bryant 120 ml — — FDA listed —
basic care childrens allergy relief 12.5 mg/5mL 72288-0379-26 Amazon.com 1 bottle — — FDA listed —
Dr Kids Allergy Relief 12.5 mg/5mL 73282-2521-01 CalmCo 24 vials — — FDA listed —
Calmco Allergy Relief 25 mg/10mL 73282-2524-02 CalmCo 18 vials — — FDA listed —
Diphenhydramine Oral Solution 12.5 mg/5mL 73564-0814-16 Aldama 1 bottle — — Discontinued —
Childrens Allergy 12.5 mg/5mL 76281-0505-24 AptaPharma 118 ml — — FDA listed —
Allergy Relief childrens 12.5 mg/5mL 79903-0175-08 WALMART 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 79903-0368-04 WALMART 1 bottle — — FDA listed —
Childrens Allergy Relief 12.5 mg/5mL 79903-0411-04 WALMART 1 bottle — — FDA listed —
Puregen Labs Allergy Relief 12.5 mg/5mL 80513-0201-16 Advanced 473 ml — — FDA listed —
Childrens Allergy Relief Dye Free Bubble Gum 12.5 mg/5mLthis 81522-0293-04 FSA 1 bottle — — Discontinued —
Kosher Meds Childrens Allergy Relief 12.5 mg/5mL 82179-0004-04 Mollec 1 bottle — — FDA listed —
Target Dye Free Childrens Allergy Relief 12.5 mg/5mL 82442-0710-08 Target 1 bottle — — FDA listed —
Childrens Allergy 12.5 mg/5mL 82673-0109-04 KinderFarms, 1 bottle — — FDA listed —
Nighttime Cold and Cough 12.5 mg/5mL 82673-0191-04 KinderFarms, 1 bottle — — FDA listed —
Allergy Relief Childrens 12.5 mg/5mL 83324-0326-04 Chain 1 bottle — — FDA listed —
QUALITY CHOICE Childrens Allergy Relief DYE FREE 12.5 mg/5mL 83324-0339-04 QUALITY 1 bottle — — FDA listed —
Diphenhydramine Hydrochloride 12.5 mg/5mL 83720-0502-04 Oncor 118 ml — — FDA listed —
Geri Dryl 12.5 mg/5mL 83939-0007-01 VERITYRX, 5 ml — — FDA listed —
M-Dryl 12.5 mg/5mL 83939-0008-01 VERITYRX, 5 ml — — FDA listed —
Revasol Childrens Allergy 12.5 mg/5mL 84379-0286-04 Rnv 118 ml — — FDA listed —
Diphenhydramine HCl Oral Solution 12.5 mg/5mL 84415-0012-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCl Oral Solution 25 mg/10mL 84415-0013-01 Everpharm 100 cups — — FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 84447-0103-01 Belleview 200000 ml — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution 12.5 mg/5mL 87078-0411-52 MEDWISE 12 pouches — — FDA listed —
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 12.5 mg/5mL 87078-0421-52 MEDWISE 12 pouches — — FDA listed —
Diphenhydramine hydrochloride 12.5 mg/5mL 31722-0600-11 Camber 1 bottle — AA FDA listed —
Diphenhydramine HCL 12.5 mg/5mL 71741-0511-04 Redmont 118 ml — AA FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Childrens Allergy Relief Dye Free Bubble Gum (this brand).

Top reported reactions

Fatigue3,537
Headache3,168
Pain3,157
Infusion Related Reaction2,800
Nausea2,742
Arthralgia2,738
Nasopharyngitis2,435

Reporter sex

0 reports

Serious outcomes

Hospitalization7,637
Death3,664
Life-threatening1,232
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,442 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81522-0293-04 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (81522-293-04) / 118 mL in 1 BOTTLE, PLASTIC 2022-04-18 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 81522-293-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 81522-0293-04, written without dashes as 81522029304. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 81522-0293-04, the first segment (81522) is the labeler code FDA assigned to FSA Store Inc. (Caring Mills); the middle segment (0293) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
FSA Store Inc. (Caring Mills) is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 86 words ▾

Directions do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product find the right dose on the chart below age (yr) dose (mL) children 6 to 11 years 5 mL to 10 mL children 2 to 5 years do not use unless directed by a doctor children under 2 years do not use

⚠️ Warnings 98 words ▾

Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if the child has a breathing problem such as chronic bronchitis glaucoma a sodium-restricted diet Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product marked drowsiness may occur sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 5 mL) Diphenhydramine HCl 12.5 mg

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients carboxymethylcellulose sodium, citric acid, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81522-0285-04 · FSA 81522-0311-11 · FSA →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.